510(k) · Cleared

Recalled · Class II · 2012

Restep Dvy System, Model RSP-101

K090308510(k) TraditionalCleared May 1, 200984-day reviewClass II21 CFR 870.5800Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stortford Medical, LLC · JOW Sleeve, Limb, Compressible

Cleared on May 1, 2009 as substantially equivalent to K991038 (Britt Corp., Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it. It has been recalled once.

Decided: May 1, 2009
Review: 84 days
Class: Class II
Product code: JOW
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K991038 (2000). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
This deviceK090308 Restep Dvy System, Model RSP-101Stortford Medical, LLC · 2009
Descendant · cites it directly · 6 of its ownK130571 Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
Descendant · cites it directly · 4 of its ownK141578 Devon Cirona 6200 DVTDevon Medical · 2014
Descendant · 2 generations on · 0 of its ownK241096 Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2025
Descendant · 2 generations on · 0 of its ownK211253 PlasmaWaveManamed, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK190975 Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010high 2 (2013) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all

K130571Devon Cirona 6100 DVTDevon Medical, Inc. · 2013 · cites it directly6descendants
K141578Devon Cirona 6200 DVTDevon Medical · 2014 · cites it directly4descendants
K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2025 · 2 generations on0descendants
K211253PlasmaWaveManamed, Inc. · 2021 · 2 generations on0descendants
K190975Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991038	Vaso Press DVT System, Models VP500, VP501	Britt Corp., Inc.	2000	—
0 (this device)	K090308	Restep Dvy System, Model RSP-101	Stortford Medical, LLC	2009	—
+1	K130571	Devon Cirona 6100 DVT	Devon Medical, Inc.	2013	—
+1	K141578	Devon Cirona 6200 DVT	Devon Medical	2014	—
+2	K241096	Venera 608 Deep Vein Thrombosis (DVT) Prevention System	Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	2025	—
+2	K211253	PlasmaWave	Manamed, Inc.	2021	—
+2	K190975	Plexus SCD110 Sequential Compression Device Sleeve	Midway Medical, LLC	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	2	0
2014	1	0
2019	2	0
2021	1	0
2025	1	0

FIG. 1 — Lineage of K090308, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K090744	FDA’s K090744 is CLARO Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Clrs Technology Corporation	2010	—
*	K991038	Vaso Press DVT System, Models VP500, VP501 Summary page 1 …leg or single leg mode. Both systems have leg and foot garments. Indications for use are similar. Vasopress DJVT System, VP500, CTC (was Britt Corp Inc.) (510Ok number K991038), in the basis that both systems use intermittent pneumatic compression to simulate muscle contractions in the legs aiding the re…	Britt Corp., Inc.	2000	—

Also cleared against K991038: 3 other devices →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130571	Devon Cirona 6100 DVT	Devon Medical, Inc.	2013	6
K141578	Devon Cirona 6200 DVT	Devon Medical	2014	4
K101087	Reprocessed Restep Compression Sleeves	Ascent Heatlhcare Solutions	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 30, 2012	Class II	Z-0840-2013	Process control	Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K130571 (Devon Medical, Inc., 2013) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K991038.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090308 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090308: Restep Dvy System, Model RSP-101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090308

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026