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# FDA 510(k) clearances and recalls: Anesthesiology devices

**12 FDA 510(k) clearances and recalls: Anesthesiology devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Suzhou Yuyue Medical Technology Co., Ltd. with 1. 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

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[Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Anesthesiology)

12 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Suzhou Yuyue Medical Technology Co., Ltd. (1). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records

12

Most frequent

- Suzhou Yuyue Medical Technology Co., Ltd. (1)
- Endovascular Engineering, Inc. (1)
- Aevice Health Pte. , Ltd. (1)
- Oxytek Medical Technology Co., Ltd. (1)
- Vitaltec Corporation (1)

## How do I get new FDA 510(k) clearances and recalls: Anesthesiology devices by email?

Search, filter and export these records, or get alerts when new ones appear.

[Search and filter](/v/fdapulse?panel=Anesthesiology) [Watch this exact filter](/v/fdapulse?panel=Anesthesiology#more-ways) [See alert plans](/v/fdapulse#pricing)

## What are the top FDA 510(k) clearances and recalls: Anesthesiology devices right now?

| Record | Specialty | Type | Date |
|---|---|---|---|
| BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. | Anesthesiology | 510(k) | 2026-10-23 |
| Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc. | Anesthesiology | 510(k) | 2026-10-11 |
| Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd. | Anesthesiology | 510(k) | 2026-09-25 |
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd. | Anesthesiology | 510(k) | 2026-09-23 |
| Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation | Anesthesiology | 510(k) | 2026-09-11 |
| Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. | Anesthesiology | 510(k) | 2026-09-18 |
| Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. | Anesthesiology | 510(k) | 2026-09-25 |
| Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. | Anesthesiology | 510(k) | 2026-09-25 |
| Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH | Anesthesiology | 510(k) | 2026-09-24 |
| ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (K260226): 510(k) cleared for Amptron Medical, Inc. | Anesthesiology | 510(k) | 2026-09-16 |
| Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd. | Anesthesiology | 510(k) | 2026-10-16 |
| Glucommander (K261939): 510(k) cleared for Glytec, LLC | Anesthesiology | 510(k) | 2026-10-05 |

[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) [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 FDA 510(k) clearances and recalls: Anesthesiology devices are listed?

12 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

### Can I get alerts for Anesthesiology?

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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