# K240499: ARTAIRA Arterial Compression Device (AACD01)

- Pathway: 510(k) (Traditional)
- Applicant: Airos Medical, Inc.
- Decided: Oct 11, 2024 after 234 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942530 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131146: Artassist and Venassist, Aci Medical, LLC (2014) Summary page 5.

## Indications for use
The ARTAIRA Arterial Compression Device’s is an intermittent pneumatic compression device intended for treatment of patients with the following conditions: • Intermittent claudication • Rest pain • Diabetic Foot • Ischemic neuritis • Arterial ulcers • Gangrene • Poor runoff.

Source page: https://510kreport.com/device/K240499
Methodology: https://510kreport.com/methodology