- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - 510(k) clearances # Recent FDA 510(k) clearances **414 recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Karl Storz SE & CO. KG with 5. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 414 recent FDA 510(k) clearances (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?record_type=clearance) 414 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Karl Storz SE & CO. KG (5). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?record_type=clearance&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?record_type=clearance) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 414 Most frequent - Karl Storz SE & CO. KG (5) - Roche Diagnostics (4) - Anhui JBH Medical Apparatus Co., Ltd. (4) - Zhenjiang Assure Medical Equipment Co., Ltd. (4) - Beckman Coulter, Inc. (3) ## How do I get new recent FDA 510(k) clearances by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?record_type=clearance) [Watch this exact filter](/v/fdapulse?record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top recent FDA 510(k) clearances right now? | Record | Specialty | Type | Date | |---|---|---|---| | OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875): 510(k) cleared for Visco Vision, Inc. | Ophthalmic | 510(k) | 2026-10-23 | | B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) | Microbiology | 510(k) | 2026-10-23 | | LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc. | Dental | 510(k) | 2026-10-23 | | BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. | Anesthesiology | 510(k) | 2026-10-23 | | Mobile Dental Solution (Model: DS50, DS70, DS90) (K260275): 510(k) cleared for Guangdong JINME Medical Technology Co., Ltd. | Dental | 510(k) | 2026-10-23 | | Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory | Other | 510(k) | 2026-10-22 | | Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc. | General Hospital | 510(k) | 2026-10-22 | | Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC | Cardiovascular | 510(k) | 2026-10-21 | | Forza (K260136): 510(k) cleared for True Function Laboratory, Inc. | Dental | 510(k) | 2026-10-06 | | STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc. | Other | 510(k) | 2026-09-24 | | TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences | Cardiovascular | 510(k) | 2026-09-21 | | BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences | Other | 510(k) | 2026-10-20 | | VenusCT (K260510): 510(k) cleared for Linatech, LLC | Radiology | 510(k) | 2026-10-19 | | 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC | Neurology | 510(k) | 2026-10-19 | | cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc. | Neurology | 510(k) | 2026-10-16 | | Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc. | Included in the full CSV with every column 🔒 Unlock all 414 records → | | BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company | Included in the full CSV with every column 🔒 Unlock all 414 records → | | Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc. | Included in the full CSV with every column 🔒 Unlock all 414 records → | Browse 35 more matching record reports - [Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.](/report/fdapulse/endox-high-level-disinfectant-k254094-de--k254094) - [BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company](/report/fdapulse/bd-vacutainer-serum-blood-collection-tubes-bd-vacutainer-nj--k252344) - [Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.](/report/fdapulse/carecube-negative-pressure-isolation-chamber-1by-k260180-ca--k260180) - [AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.](/report/fdapulse/aview-aorta-metrics-k260391-kr--k260391) - [Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation](/report/fdapulse/small-diameter-core-wire-cman-000-00-small-diameter-core-tx--k260168) - [Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.](/report/fdapulse/medi-astro-total-and-partial-ossicular-prostheses-type-torp-cn--k260264) - [TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.](/report/fdapulse/tecar-therapy-device-tc2000-tc2001-k252288-cn--k252288) - [Helo™ Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.](/report/fdapulse/helo-return-k253717-ca--k253717) - [TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC](/report/fdapulse/truvision-single-use-1-9mm-arthroscopy-system-k260156-ut--k260156) - [Wishbone HAE (K260096): 510(k) cleared for Wishbone SA](/report/fdapulse/wishbone-hae-k260096-be--k260096) - [Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.](/report/fdapulse/pro-line-xl-power-injectable-central-venous-catheter-and-pa--k260080) - [eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.](/report/fdapulse/eclinics-k260075-ny--k260075) - [Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.](/report/fdapulse/vista-ai-scan-k260092-ca--k260092) - [MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.](/report/fdapulse/myovista-wavecg-dg-200-b15-003-k260005-tx--k260005) - [Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.](/report/fdapulse/neurora-k260064-nh--k260064) - [Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.](/report/fdapulse/ventricular-catheters-thomale-catheter-k260044-pa--k260044) - [Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-ebv-ebna-igg-k260221-in--k260221) - [OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.](/report/fdapulse/oab-delivery-catheter-k253422-ga--k253422) - [cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.](/report/fdapulse/ccell405-k254030-kr--k254030) - [Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-ebv-vca-igg-k260232-in--k260232) - [Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-ebv-igm-k260233-in--k260233) - [Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co.](/report/fdapulse/firstar-dental-handpieces-k260029-wa--k260029) - [VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.](/report/fdapulse/vitek-2-ast-streptococcus-meropenem-0-06-4-g-ml-k260283-mo--k260283) - [Firstar Dental Electric Motor (K260027): 510(k) cleared for FDC Technology Industry Co.](/report/fdapulse/firstar-dental-electric-motor-k260027-wa--k260027) - [ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.](/report/fdapulse/ecg-analysis-software-aitialvsd-k254302-kr--k254302) - [QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.](/report/fdapulse/qca-10-electrocardiograph-qcard-10-qca-10w-ca--k260250) - [THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH](/report/fdapulse/thermeo-i-msi-k260031-de--k260031) - [Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.](/report/fdapulse/kentrospine-viktr-mis-pedicle-screw-system-k252139-in--k252139) - [REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210): 510(k) cleared for Hyundai Bioland Co., Ltd.](/report/fdapulse/rebohil-bgm-1-bgm-2-bgm-3-bgm-4-bgm-5-k254210-kr--k254210) - [DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies](/report/fdapulse/distasense-tm-v1-k254058-ca--k254058) - [easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.](/report/fdapulse/easyendo-e-lite-single-use-powered-endoscopic-staplers-cn--k254291) - [TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.](/report/fdapulse/tumorsight-risk-k260023-il--k260023) - [Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.](/report/fdapulse/aevice-wheeze-detection-module-k260140-sg--k260140) - [CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.](/report/fdapulse/capsoview-cvv-capsocloud-cld-k254230-ca--k254230) - [UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG](/report/fdapulse/unidrive-siii-system-hopkins-telescope-0o-26205ama-de--k254252) More records in this hub: [page 2](/hub/fdapulse/type/510k-clearances/page/2) · [page 3](/hub/fdapulse/type/510k-clearances/page/3) · [page 4](/hub/fdapulse/type/510k-clearances/page/4) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many recent FDA 510(k) clearances are listed? 414 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for 510(k) clearances? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.