# K193069: AIROS 6 Sequential Compression Device

- Pathway: 510(k) (Special)
- Applicant: Airos Medical, Inc.
- Decided: Dec 4, 2019 after 30 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: 6 generations back to K810338 (1981). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172770: AIROS 6 Sequential Compression Device, Airos Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K223195: AIROS 6P Sequential Compression Device (2022), 1 descendant of its own
- K251086: PnueAira (PNCU-01) (2025), 0 descendants of its own

## Indications for use
The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is safe for both home and hospital use.

Source page: https://510kreport.com/device/K193069
Methodology: https://510kreport.com/methodology