# K090308: Restep Dvy System, Model RSP-101

- Pathway: 510(k) (Traditional)
- Applicant: Stortford Medical, LLC
- Decided: May 1, 2009 after 84 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: 1 generation back to K991038 (2000). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991038: Vaso Press DVT System, Models VP500, VP501, Britt Corp., Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K090744: CLARO, Clrs Technology Corporation (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130571: Devon Cirona 6100 DVT (2013), 6 descendants of its own
- 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

## Recalls of this device
- Aug 30, 2012 · Class II · Z-0840-2013: Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.

## Indications for use
The Restep DVT System is a prescriptive device that helps stimulate blood flow in the deep veins of the legs and is intended for use in:- Preventing Deep Vein Thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, neurology, urologic, critical care, general medicine obstetrics and general surgery.

Source page: https://510kreport.com/device/K090308
Methodology: https://510kreport.com/methodology