# K130571: Devon Cirona 6100 DVT

- Pathway: 510(k) (Traditional)
- Applicant: Devon Medical, Inc.
- Decided: Apr 9, 2013 after 36 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: 2 generations back to K991038 (2000). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961166: Flowtron Excel Pump, Hne Healthcare, Inc. (1996) Summary page 1.
- K991038: Vaso Press DVT System, Models VP500, VP501, Britt Corp., Inc. (2000) Summary page 1.
- K090308: Restep Dvy System, Model RSP-101, Stortford Medical, LLC (2009) Summary page 1.
- K010744: Flowtron Universal, Model AC600, Huntleigh Healthcare, Inc. (2002) Summary page 1.

## Most influential descendants
- K141578: Devon Cirona 6200 DVT (2014), 4 descendants of its own
- K241096: Venera 608 Deep Vein Thrombosis (DVT) Prevention System (2025), 0 descendants of its own
- K211253: PlasmaWave (2021), 0 descendants of its own
- K190975: Plexus SCD110 Sequential Compression Device Sleeve (2019), 0 descendants of its own
- K182578: Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device (2019), 0 descendants of its own

## Indications for use
The Cirona TM 6100 system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

Source page: https://510kreport.com/device/K130571
Methodology: https://510kreport.com/methodology