510(k) · Cleared

Cleared

Reprocessed Compression Sleeves

K024074510(k) TraditionalCleared Mar 7, 200387-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

Alliance Medical Corp. · JOW Sleeve, Limb, Compressible

Cleared on Mar 7, 2003 as substantially equivalent to K961405 (Alba-Waldensian, Inc., 1996) after an 87-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Mar 7, 2003
Review: 87 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K961405 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK961405 Alba Health Pas Wrap SystemAlba-Waldensian, Inc. · 1996 · Recalled
This deviceK024074 Reprocessed Compression SleevesAlliance Medical Corp. · 2003
Descendant · cites it directly · 0 of its ownK100909 Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961405	Alba Health Pas Wrap System	Alba-Waldensian, Inc.	1996	1
0 (this device)	K024074	Reprocessed Compression Sleeves	Alliance Medical Corp.	2003	—
+1	K100909	Reprocessed Compression Sleeves	Ascent Healthcare Solutions	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K024074, 1996–2010Source: 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
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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
*	K961405	Alba Health Pas Wrap System Summary page 2 …ession Sleeve Classification Name: Compressible Limb Sleeve Predicate device(s): K Number Device Description K961405 AlbahealthTMPAS Wrap System Device Compression sleeves are part of an external compression system, in…	Alba-Waldensian, Inc.	1996	1

Also cleared against K961405: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100909	Reprocessed Compression Sleeves	Ascent Healthcare Solutions	2010	0

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?

Its one ancestor has a recall.
Of its descendants, K100909 (Ascent Healthcare Solutions, 2010) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K961405.

How does its category compare?

All JOW devices

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

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?

Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024074 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024074: Reprocessed Compression Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024074

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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