Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airos Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
281 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024-10-11 | 234 | 0 |
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 | 57 | 0 |
| K223193 | AIROS 8P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 | 57 | 0 |
| K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2019-12-04 | 30 | 0 |
| K193068 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | 2019-12-04 | 30 | 0 |
| K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2018-06-22 | 281 | 0 |
| K172779 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | 2018-06-22 | 281 | 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