# Airs Medical, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 7 (2021–2026): 7 510(k) clearances
- Product codes: LLZ (3), QIH (3), LNH (1)
- 510(k) review time since 2016: median 132 days, against 130 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Subtle Medical, Inc.: 1 (https://510kreport.com/company/subtle-medical)
- Neurophet., Inc.: 1 (https://510kreport.com/company/neurophet)

## Firms that cite its devices most
- Subtle Medical, Inc.: 1 (https://510kreport.com/company/subtle-medical)
- Foqus Technologies, Inc.: 1 (https://510kreport.com/company/foqus-technologies)

## Its most-cited devices
- K210999: SwiftMR (2021), cited by 2
- K230854: SwiftMR (2023), cited by 2
- K253775: SwiftMR (2026), cited by 1
- K220416: SwiftMR (2022), cited by 1

## Recent decisions
- K261612: SwiftSight-BodyComposition (Oct 1, 2026)
- K261349: SwiftMR (Jul 24, 2026)
- K253775: SwiftMR (Mar 26, 2026)
- K251483: SwiftSight-Brain (Sep 23, 2025)
- K230854: SwiftMR (Oct 27, 2023)
- K220416: SwiftMR (May 25, 2022)
- K210999: SwiftMR (Oct 14, 2021)

Source page: https://510kreport.com/company/airs-medical