# K010744: Flowtron Universal, Model AC600

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Mar 26, 2002 after 378 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
No predicates in its family tree.
21 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130571: Devon Cirona 6100 DVT (2013), 6 descendants of its own
- K110977: Vesoflow (2011), 6 descendants of its own
- K141064: Vesoflow Plus DVT Compression Device (2014), 4 descendants of its own
- K141578: Devon Cirona 6200 DVT (2014), 4 descendants of its own
- K133119: Flowtron ACS800 Pump and Tri Pulse Garments (2014), 2 descendants of its own

## Recalls of this device
- Dec 10, 2012 · Class II · Z-0615-2013: The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

Source page: https://510kreport.com/device/K010744
Methodology: https://510kreport.com/methodology