# K143438: Flowtron ACS900

- Pathway: 510(k) (Traditional)
- Applicant: Getinge (Suzhou) Co., Ltd.
- Decided: Jun 23, 2015 after 203 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890938 (1989). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133119: Flowtron ACS800 Pump and Tri Pulse Garments, Arjohuntleigh Polska SP Z.O.O. (2014) Summary page 4.

## Most influential descendants
- K191937: Ezvena IPC, Ezvena SQS (2020), 0 descendants of its own

## Recalls of this device
- Jun 14, 2017 · Class II · Z-2714-2017: Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

## Indications for use
To help prevent Deep Vein Thrombosis (DVT)

Source page: https://510kreport.com/device/K143438
Methodology: https://510kreport.com/methodology