510(k) · Cleared

Cleared

Sterilmed Reprocessed Compression Sleeves

K012597510(k) TraditionalCleared Feb 11, 2002185-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

Sterilmed, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Feb 11, 2002 as substantially equivalent to K781357 (Kendall Research Center, 1978) and 3 other predicates after a 185-day review. Its family tree reaches back 1 generation to 1978. 1 later device descends from it.

Decided: Feb 11, 2002
Review: 185 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K781357 (1978). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK781357 T.E.D. Sequential Compression SleevesKendall Research Center · 1978 · Recalled
This deviceK012597 Sterilmed Reprocessed Compression SleevesSterilmed, Inc. · 2002
Descendant · cites it directly · 0 of its ownK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006

Most influential descendants

Showing 1 of 1 · See all

K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K781357	T.E.D. Sequential Compression Sleeves	Kendall Research Center	1978	1
0 (this device)	K012597	Sterilmed Reprocessed Compression Sleeves	Sterilmed, Inc.	2002	—
+1	K052691	Suretek Medical Reprocessed Compression Sleeves	Suretek Medical	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K012597, 1978–2006Source: 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? (4)

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
*	K781357	T.E.D. Sequential Compression Sleeves Summary page 1 …d Compression Sleeves Class II, 21 CFR 870.5800 JOW SterilMed’s reprocessed compression sleeves are substantially equivalent to the Kendall Company models 5329, 5330 (K781357) 5065, 5066, and 5075 (K953648 and K951683), and the Huntleigh Technology Inc. models GS337M and GS334 (K910188), and to the orig…	Kendall Research Center	1978	1
*	K953648	A-V Impulse System Model 6060 Summary page 1 …, 21 CFR 870.5800 JOW SterilMed’s reprocessed compression sleeves are substantially equivalent to the Kendall Company models 5329, 5330 (K781357) 5065, 5066, and 5075 (K953648 and K951683), and the Huntleigh Technology Inc. models GS337M and GS334 (K910188), and to the original manufacturers” devices. R…	Novamedix, Ltd.	1996	—
*	K951683	A-V Impulse System Model 6060 Summary page 1 ….5800 JOW SterilMed’s reprocessed compression sleeves are substantially equivalent to the Kendall Company models 5329, 5330 (K781357) 5065, 5066, and 5075 (K953648 and K951683), and the Huntleigh Technology Inc. models GS337M and GS334 (K910188), and to the original manufacturers” devices. Reprocessed C…	Novamedix, Ltd.	1995	2
*	K910188	Flowplus AC330 Pump Garments Summary page 1 …ally equivalent to the Kendall Company models 5329, 5330 (K781357) 5065, 5066, and 5075 (K953648 and K951683), and the Huntleigh Technology Inc. models GS337M and GS334 (K910188), and to the original manufacturers” devices. Reprocessed Compression Sleeves are inflatable devices that are fitted to a patien…	Huntleigh Technology, Inc.	1991	—

Also cleared against K781357: 4 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
K052691	Suretek Medical Reprocessed Compression Sleeves	Suretek Medical	2006	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?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K052691 (Suretek Medical, 2006) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K781357.

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?

These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external intermittent or sequential limb compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012597: Sterilmed Reprocessed Compression Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012597

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026