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- General Hospital devices: recent FDA 510(k) clearances

# General Hospital devices: recent FDA 510(k) clearances

**14 general Hospital devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22; the most frequent is B.Braun Medical, Inc. with 1. Data last updated 2026-11-04; each record links to its official source and a full report.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation

Download all 14 general Hospital devices: recent FDA 510(k) clearances (CSV) — $4.99 →

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[Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=General%20Hospital&record_type=clearance)

14 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22. Most frequent: B.Braun Medical, Inc. (1). Each record links to a full report and the official source.

Last updated 2026-11-04. Source: U.S. FDA openFDA.

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Records

14

Most frequent

- B.Braun Medical, Inc. (1)
- Whiteley USA, Inc. (1)
- Carecubes, Inc. (1)
- Medical Components, Inc. (1)
- Ecomed Solutions, LLC (1)

## How do I get new general Hospital devices: 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?panel=General%20Hospital&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=General%20Hospital&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing)

## What are the top general Hospital devices: recent FDA 510(k) clearances right now?

| Record | Specialty | Type | Date |
|---|---|---|---|
| Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc. | General Hospital | 510(k) | 2026-10-22 |
| Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc. | General Hospital | 510(k) | 2026-10-16 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc. | General Hospital | 510(k) | 2026-10-16 |
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. | General Hospital | 510(k) | 2026-10-09 |
| Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC | General Hospital | 510(k) | 2026-09-11 |
| 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products | General Hospital | 510(k) | 2026-09-18 |
| MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD | General Hospital | 510(k) | 2026-09-17 |
| S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda | General Hospital | 510(k) | 2026-10-22 |
| Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific | General Hospital | 510(k) | 2026-10-16 |
| Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. | General Hospital | 510(k) | 2026-10-14 |
| TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan | General Hospital | 510(k) | 2026-10-06 |
| Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe | General Hospital | 510(k) | 2026-10-01 |
| 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC | General Hospital | 510(k) | 2026-09-25 |
| NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical | General Hospital | 510(k) | 2026-09-18 |

[Browse all FDAPulse record reports](/hub/fdapulse/records)

## Which related categories and locations should I check?

### Browse by record type

[510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [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) [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 general Hospital devices: recent FDA 510(k) clearances are listed?

14 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-22.

### Can I get alerts for General Hospital devices: recent FDA 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)

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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.
