# Aqua Medical, Inc.

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 5 (2019–2025): 5 510(k) clearances
- Product codes: KNS (5)
- 510(k) review time since 2016: median 109 days, against 139 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 12 (10 its own); citations of its devices by later devices: 10 (10 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
- Barrx Medical, Incorporated: 2 (https://510kreport.com/company/barrx-medical)

## Its most-cited devices
- K183595: Aqua Medical RF Vapor System (2019), cited by 4
- K211282: Aqua Medical RF Vapor System (2021), cited by 3
- K213627: RF Vapor System (2021), cited by 2
- K241271: Aqua Medical RF Vapor Ablation System (2024), cited by 1

## Recent decisions
- K251226: Aqua Medical RF Vapor Ablation System (Aug 8, 2025)
- K241271: Aqua Medical RF Vapor Ablation System (Dec 12, 2024)
- K213627: RF Vapor System (Dec 17, 2021)
- K211282: Aqua Medical RF Vapor System (May 27, 2021)
- K183595: Aqua Medical RF Vapor System (Jun 21, 2019)

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