# K131146: Artassist and Venassist

- Pathway: 510(k) (Traditional)
- Applicant: Aci Medical, LLC
- Decided: Feb 10, 2014 after 293 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: 1 generation back to K942530 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942530: Art-Assist Model AA-1000, Aci Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K240499: ARTAIRA Arterial Compression Device (AACD01) (2024), 0 descendants of its own

## Indications for use
When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot schemic neuritis Arterial ulcers Gangrene Poor runoff

Source page: https://510kreport.com/device/K131146
Methodology: https://510kreport.com/methodology