Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aqua Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
220 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2025-08-08 | 109 | 0 |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024-12-12 | 220 | 0 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | 2021-12-17 | 30 | 0 |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021-05-27 | 30 | 0 |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019-06-21 | 182 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda