# K131327: Bioarterial Plus Arterial Blood Flow Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Jul 18, 2013 after 71 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: 3 generations back to K881632 (1988). 10 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System, Bio Compression Systems, Inc. (2007) Summary page 4.

## Most influential descendants
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), 12 descendants of its own
- K190854: Therm-X (2019), 11 descendants of its own
- K193550: Therm-X (2020), 10 descendants of its own
- K223729: FLOWpresso (2023), 3 descendants of its own
- K232965: Leg Massager (Models:RP-ALM070H, RP-ALM071H) (2024), 2 descendants of its own

## Indications for use
The IC-BAP-OL. BloArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with isohemnic 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 * lschemnia * Night pain * Rest pain * Small vessel disease * Ulcers

Source page: https://510kreport.com/device/K131327
Methodology: https://510kreport.com/methodology