Airos Medical, Inc.: FDA clearances and approvals
Airos Medical, Inc. has 7 FDA 510(k) clearances (first 2018, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time: 57 days. Since 2017 its median was 57 days, against 134 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 281 |
| 2019 | 2 | 30 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 57 |
| 2023 | 0 | — |
| 2024 | 1 | 234 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Airos Medical, Inc.'s cleared 510(k)s took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Airos Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | JOW | 2024-10-11 | 234 |
| K223195 | AIROS 6P Sequential Compression Device | JOW | 2022-12-09 | 57 |
| K223193 | AIROS 8P Sequential Compression Device | JOW | 2022-12-09 | 57 |
| K193069 | AIROS 6 Sequential Compression Device | JOW | 2019-12-04 | 30 |
| K193068 | AIROS 8 Sequential Compression Device | JOW | 2019-12-04 | 30 |
| K172779 | AIROS 8 Sequential Compression Device | JOW | 2018-06-22 | 281 |
| K172770 | AIROS 6 Sequential Compression Device | JOW | 2018-06-22 | 281 |
Recalls
openFDA lists no recalls under a recalling firm named Airos Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Airos Medical, Inc. have?
Airos Medical, Inc. has 7 FDA 510(k) clearances (first 2018, latest 2024), across 1 product code in 1 review panel.
How long does FDA take to clear Airos Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Airos Medical, Inc.'s cleared 510(k)s is 57 days. Since 2017: 57 days, versus 134 days for all cleared 510(k)s in the same product codes.
What devices does Airos Medical, Inc. make?
Its most frequent FDA product codes are JOW (Sleeve, Limb, Compressible, 7).
Has Airos Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Airos Medical, Inc. Related entities may recall under other names.
Next steps
- See all 7 Airos Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Airos Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.