# K012008: STS Range , Models STS20,STS30,STS40

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Sep 21, 2001 after 86 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 K890938 (1989). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890938: Kendall SCD Therapeutic System, Kendall Healthcare Products Co. Div.Of Tyco Health (1989) Summary page 1.

## Most influential descendants
- K133119: Flowtron ACS800 Pump and Tri Pulse Garments (2014), 2 descendants of its own
- K143438: Flowtron ACS900 (2015), 1 descendant of its own
- K191937: Ezvena IPC, Ezvena SQS (2020), 0 descendants of its own

## Indications for use
The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

Source page: https://510kreport.com/device/K012008
Methodology: https://510kreport.com/methodology