# K961166: Flowtron Excel Pump

- Pathway: 510(k) (Traditional)
- Applicant: Hne Healthcare, Inc.
- Decided: Oct 11, 1996 after 200 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
No predicates in its family tree.
42 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Flowtron®DVT: named in the summary without a submission number
- (no number) AC500: named in the summary without a submission number

## Most influential descendants
- K061125: Dvtcare CA5 (2006), 30 descendants of its own
- K103187: Tripleplay-VT Vascular Therapy System (2011), 25 descendants of its own
- K133274: Vena Pro (2014), 22 descendants of its own
- K130571: Devon Cirona 6100 DVT (2013), 6 descendants of its own
- K151189: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System (2015), 5 descendants of its own

## Indications for use
The AC550 Flowtron®Excel pump, coupled with the Flowtron DVT compression garments, is an external pneumatic compression system used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians.

Source page: https://510kreport.com/device/K961166
Methodology: https://510kreport.com/methodology