# Airsep Corp.

- Location (FDA's records): Buffalo, NY
- FDA decisions: 19 (1987–2015): 19 510(k) clearances
- Names in FDA's records: Airsep Corp. (18); Airsep Corporation (1)
- Product codes: CAW (8), CAF (2), NFB (2), OLV (2), FLS (1), GWE (1), DQA (1), BZD (1), GWF (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 18 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sequal Technologies, Inc.: 1 (https://510kreport.com/company/sequal-technologies)
- On Site Gas Systems, Inc.: 1 (https://510kreport.com/company/on-site-gas-systems)
- Nonin Medical, Inc.: 1 (https://510kreport.com/company/nonin-medical)

## Firms that cite its devices most
- Medcare Flaga: 3 (https://510kreport.com/company/medcare-flaga)
- Medical Electronic Devices, Inc.: 2 (https://510kreport.com/company/medical-electronic-devices)
- Merits Health Products Co., Ltd.: 2 (https://510kreport.com/company/merits-health-products)
- Oxytec Medical Corporation: 1 (https://510kreport.com/company/oxytec-medical)
- Sysmed (China) Co., Ltd.: 1 (https://510kreport.com/company/sysmed-china)
- Embla Systems: 1 (https://510kreport.com/company/embla-systems)
- Braebon Medical Corp.: 1 (https://510kreport.com/company/braebon-medical)
- Inogen, Inc.: 1 (https://510kreport.com/company/inogen)

## Its most-cited devices
- K020324: Lifestyle Oxygen Concentrator (2002), cited by 5
- K150930: Deployable Oxygen Generation System-Smaill (DOGS-S) (2015), cited by 3
- K962865: Rembrandt System (1996), cited by 3
- K960309: Airsep Newlife Dual Six Oxygen Concentrator (Modification) (1997), cited by 2
- K992283: Artisan Acquisition System for Eeg and Polysomnography (1999), cited by 1
- K001013: Monet Acquisition System for Eeg and Polysomnography (2000), cited by 1

## Recent decisions
- K150930: Deployable Oxygen Generation System-Smaill (DOGS-S) (Dec 18, 2015)
- K101154: Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L (Mar 28, 2011)
- K080348: Oxiscan II Data Management System (Oct 9, 2008)
- K020324: Lifestyle Oxygen Concentrator (Mar 13, 2002)
- K012037: Healthlife Oxygen Concentrator Model AS009 (Jan 17, 2002)
- K000963: DA Vinchi Eeg and Emg/EP Systems (Oct 20, 2000)
- K001579: Impulse Select (Aug 31, 2000)
- K001467: DA Vinchi Emg/EP ISA1004EP (Aug 1, 2000)

Source page: https://510kreport.com/company/airsep