# K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Nov 5, 2007 after 45 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 K881632 (1988). 9 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061857: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator, Bio Compression Systems, Inc. (2006) Summary page 2.
- K942530: Art-Assist Model AA-1000, Aci Medical, Inc. (1996) Summary page 2.
- K914461: A-V Impulse System, Novamedix, Ltd. (1992) Summary page 2.
- K951683: A-V Impulse System Model 6060, Novamedix, Ltd. (1995) Summary page 2.
- K953648: A-V Impulse System Model 6060, Novamedix, Ltd. (1996) Summary page 2.

## Most influential descendants
- K131327: Bioarterial Plus Arterial Blood Flow Enhancement System (2013), 14 descendants of its own
- 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

## Indications for use
The BioArterial Plus Arterial Blood Flow Enhancement System is intended 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/K072666
Methodology: https://510kreport.com/methodology