Data / Medical devices / United States / Airos Medical Inc
Airos Medical Inc: FDA-registered device maker in Audubon, PA, United States, 12 510(k) clearances
Airos Medical Inc is registered with the FDA (registration 3014491159) in Audubon, PA, United States. It lists 1 device type. The FDA files 12 510(k) clearances under its listings, the newest dated October 11, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014491159
- Address
- 2501 Monroe BLVD Ste 1200, Audubon, PA, United States, 19403
- Owner or operator
- AIROS Medical, Inc. (10058005)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 25, 2018
- Registered through
- 2027
- Brand names listed
- AIROS 6 Sequential Compression Device, AIROS 6P Sequential Compression Device, AIROS 8 Sequential Compression Device, AIROS 8P Sequential Compression Device, ArterioFlow 7500 Sequential Compression Device, ArterioFlow 7502 Sequential Compression Device, CircuFlow 5100 Sequential Compression Device, CircuFlow 5150 Sequential Compression Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 11, 2024 | K240499 | ARTAIRA Arterial Compression Device (AACD01) | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| December 9, 2022 | K223195 | AIROS 6P Sequential Compression Device | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| December 9, 2022 | K223193 | AIROS 8P Sequential Compression Device | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| December 4, 2019 | K193069 | AIROS 6 Sequential Compression Device | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| December 4, 2019 | K193068 | AIROS 8 Sequential Compression Device | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| June 22, 2018 | K172779 | AIROS 8 Sequential Compression Device | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| June 22, 2018 | K172770 | AIROS 6 Sequential Compression Device | JOW | Substantially Equivalent | Airos Medical, Inc. | accessdata.fda.gov |
| February 28, 2013 | K123959 | CIRCUFLOW 5150 | JOW | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
| February 14, 2013 | K123647 | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE | JOW | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
| October 7, 2010 | K102582 | ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE | JOW | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
| June 17, 2010 | K101523 | CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE | JOW | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
| March 5, 2010 | K100446 | CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE | JOW | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.