510(k) · Cleared

Cleared

Reprocessed Restep Compression Sleeves

K101087510(k) TraditionalCleared Jul 16, 201088-day reviewClass II21 CFR 870.5800

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

Ascent Heatlhcare Solutions · JOW Sleeve, Limb, Compressible

Cleared on Jul 16, 2010 as substantially equivalent to K090308 (Stortford Medical, LLC, 2009) after an 88-day review. Its family tree reaches back 2 generations to 2000.

Decided: Jul 16, 2010
Review: 88 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K991038 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
1 generation backK090308 Restep Dvy System, Model RSP-101Stortford Medical, LLC · 2009 · Recalled
This deviceK101087 Reprocessed Restep Compression SleevesAscent Heatlhcare Solutions · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K991038	Vaso Press DVT System, Models VP500, VP501	Britt Corp., Inc.	2000	—
−1	K090308	Restep Dvy System, Model RSP-101	Stortford Medical, LLC	2009	1
0 (this device)	K101087	Reprocessed Restep Compression Sleeves	Ascent Heatlhcare Solutions	2010	—

FIG. 1 — Lineage of K101087, 2000–2010Source: 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? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K090308	Restep Dvy System, Model RSP-101 Summary page 1 …: Compression Sleeve Classification Name: Compressible Limb Sleeve Predicate Devices 510(k) Title Manufacturer K090308 Restep DVT System Stortford Medical LLC Device description: The Restep Deep Vein Th…	Stortford Medical, LLC	2009	1

Also cleared against K090308: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K090308.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101087 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101087: Reprocessed Restep Compression Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101087

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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