Airos Medical Inc
Audubon, PA, US
AIROS MEDICAL INC appears in FDA device records in Audubon, PA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Airos Medical Inc between 2018 and 2024. The busiest year on record is 2018, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2019 | 2 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | JOW | Substantially Equivalent | |
| K223195 | AIROS 6P Sequential Compression Device | JOW | Substantially Equivalent | |
| K223193 | AIROS 8P Sequential Compression Device | JOW | Substantially Equivalent | |
| K193069 | AIROS 6 Sequential Compression Device | JOW | Substantially Equivalent | |
| K193068 | AIROS 8 Sequential Compression Device | JOW | Substantially Equivalent | |
| K172779 | AIROS 8 Sequential Compression Device | JOW | Substantially Equivalent | |
| K172770 | AIROS 6 Sequential Compression Device | JOW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014491159 | 3014491159 | AIROS MEDICAL INC | 2501 MONROE BLVD STE 1200, Audubon, PA 19403 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain