# K250974: Bio Arterial Deluxe (IC-BAP-DX)

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Dec 12, 2025 after 256 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: 4 generations back to K881632 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131327: Bioarterial Plus Arterial Blood Flow Enhancement System, Bio Compression Systems, Inc. (2013) Summary page 5.

## Indications for use
The Bio Arterial Deluxe Arterial Blood Flow Enhancement System is intended: * For the improvement of blood circulation in the upper and lower extremities to help prevent and reduce complications of poor circulation * For treatment of patients with intermittent claudication, rest pain, diabetic foot, ischemic neuritis, arterial ulcers, gangrene, poor runoff * As an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: amputations (minor), angioplasty/stent failure, arteriopathic wounds, graft failure, intermittent claudication, ischemia, night pain, rest pain, small vessel disease, ulcers

Source page: https://510kreport.com/device/K250974
Methodology: https://510kreport.com/methodology