Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airs Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
213 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261349 | SwiftMR | Airs Medical, Inc. | 2026-07-24 | 91 | 0 |
| K253775 | SwiftMR | Airs Medical, Inc. | 2026-03-26 | 120 | 0 |
| K251483 | SwiftSight-Brain | Airs Medical, Inc. | 2025-09-23 | 132 | 0 |
| K230854 | SwiftMR | Airs Medical, Inc. | 2023-10-27 | 213 | 0 |
| K220416 | SwiftMR | Airs Medical, Inc. | 2022-05-25 | 100 | 0 |
| K210999 | SwiftMR | Airs Medical, Inc. | 2021-10-14 | 195 | 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