# K251086: PnueAira (PNCU-01)

- Pathway: 510(k) (Traditional)
- Applicant: Biotab, LLC
- Decided: Aug 18, 2025 after 131 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: 8 generations back to K810338 (1981). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223195: AIROS 6P Sequential Compression Device, Airos Medical, Inc. (2022) Summary page 6.
- K182003: Lympha Press Optimal Plus, Mego Afek AC, Ltd. (2019) Summary page 6.

## Indications for use
The PnueAira device and garments for legs and core are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as: • Lymphedema • Primary lymphedema • Post mastectomy edema • Edema following trauma and sports issues • Post immobilization edema • Venous insufficiency • Reducing wound healing time • Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, and diabetic leg ulcers • Lipedema

Source page: https://510kreport.com/device/K251086
Methodology: https://510kreport.com/methodology