510(k) · Cleared

Cleared

Renu Medical Reporcessed Compressible Limb Sleeves

K031559510(k) TraditionalCleared Nov 12, 2003177-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

Renu Medical, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Nov 12, 2003 as substantially equivalent to K021509 (Hygia Health Services, Inc., 2002) and 6 other predicates after a 177-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.

Decided: Nov 12, 2003
Review: 177 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K012417 (2002). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK012417 Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329…Hygia Health Services, Inc. · 2002
This deviceK031559 Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003
Descendant · cites it directly · 2 of its ownK051227 Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006
Descendant · cites it directly · 0 of its ownK203847 Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK093658 Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu…Renu Medical, Inc. · 2010
Descendant · 2 generations on · 0 of its ownK080551 University Health Care Processed Alternating Leg Pressure (Uhc Apl)…University of Utah Hospitals and Clinics · 2008

Most influential descendants

Showing 4 of 4 · See all

K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006 · cites it directly2descendants
K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021 · cites it directly0descendants
K093658Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot…Renu Medical, Inc. · 2010 · 2 generations on0descendants
K080551University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve DeviceUniversity of Utah Hospitals and Clinics · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012417	Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330…	Hygia Health Services, Inc.	2002	—
0 (this device)	K031559	Renu Medical Reporcessed Compressible Limb Sleeves	Renu Medical, Inc.	2003	—
+1	K051227	Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1	Renu Medical, Inc.	2006	—
+1	K203847	Reprocessed Tri Pulse Compression Garment	Renu Medical, Inc.	2021	—
+2	K093658	Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical…	Renu Medical, Inc.	2010	—
+2	K080551	University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve…	University of Utah Hospitals and Clinics	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	6	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2010	1	0
2021	1	0

FIG. 1 — Lineage of K031559, 2002–2021Source: 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

Get a 510(k) Report

What was it cleared against? (15)

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
*	K021509	Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089 Summary page 2 …mpulse System Rigid Sole Foot Cover Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Slecve Class IT Hygia Health Services Reprocessed Novamedix ImPad® K021509 Compressible Limb Sleeve Intermittent Pneumnatic Compressible Limb Sleeve Class 11 Huntleigh DVT Compression Slccves Compress…	Hygia Health Services, Inc.	2002	—
*	K012654	Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20… Summary page 2 …11 Huntleigh DVT Compression Slccves Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Class 11 Hygia Health Services Reprocessed Huntlcigh DVT K012654 : Compressible Limb Slecve Intermittent Pneumatic Compressible Limb Sleeve Class IT Huntleigh Foot Wrap . Compressible Limb Sl…	Hygia Health Services, Inc.	2002	—
*	K012651	Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 Summary page 2 …ss IT Huntleigh Foot Wrap . Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Class II Hygia Health Services Reprocessed Huntleigh Foot Wrap KO012651 Hygia West 9800 Evergreen Way ® Everett, WA, 98204 VOICE 425-353-1110 ® FAX 425-353-9116 SIIB-ESE (SZ2b) -oUu] IE9IPSW NNIN d…	Hygia Health Services, Inc.	2002	—
*	K012657	Hygia Health Services Reprocessed Nutech Calf Wrap Summary page 3 …Slceve Class 11 NuTech Calf Wrap : Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Class II Hygia Health Services Reprocessed NuTech Calf Wrap K012657 : Compressible Limb Sleeve Intermirtent Pneumatic Compressible Limb Sleeve Class I NuTech Combo : Compressible Limb Sleeve Inte…	Hygia Health Services, Inc.	2002	—
*	K012956	Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb Summary page 3 …ible Limb Sleeve Class I NuTech Combo : Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Class 11 Hygia Health Services Reprocessed NuTech Combo K012956 : Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sieeve Class II NuTech Plexipulse System : Compressible Lim…	Hygia Health Services, Inc.	2002	—
*	K012650	Hygia Health Services Reprocessed Nutech Foot Wrap Summary page 3 …lass II NuTech Plexipulse System : Compressible Limb Sleeve Intermittent Pneumnatic Compressible Limb Sleeve Class T Hygia Health Services Reprocesscd NuTech Plexipulse K012650 : Compressible Limb Sleceve Intermittent Pneumnatic Compressible Limb Sleeve Class 11 Kendall SCD Hygia West 9800 Evergreen Wa…	Hygia Health Services, Inc.	2002	—
*	K012417	Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480 Summary page 4 …Common Name: Intermittent Pncumatic Compressible Limb Sleeve Classification: Class 11 Proprietary Name: ~ Hygia Health Services Reprocessed Kendall SCD 510(k) number:; K012417 Classification Name: Compressible Limb Sleeve Common Name: Intermittent Pneumatic Compressible Limb Sleeve Classification: Clas…	Hygia Health Services, Inc.	2002	—
*	—	Novamedix ImPad® A-V Impulse System Rigid Sole Foot Cover Named without a submission number			—
*	—	Huntleigh DVT Compression Sleeves Named without a submission number			—
*	—	Huntleigh Foot Wrap Named without a submission number			—
*	—	NuTech Calf Wrap Named without a submission number			—
*	—	NuTech Combo Named without a submission number			—
*	—	NuTech Plexipulse System Named without a submission number			—
*	—	Kendall SCD Named without a submission number			—
*	—	Microtek Medical Venodyne Sleeve Named without a submission number			—

Also cleared against K021509: 2 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K051227	Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1	Renu Medical, Inc.	2006	2
K203847	Reprocessed Tri Pulse Compression Garment	Renu Medical, Inc.	2021	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?

None of the 7 ancestors has a recall.
Of its descendants, K051227 (Renu Medical, Inc., 2006) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K021509.

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?

The Hygia West Reprocessed Huntleigh DVT Sleeve is to be used by patients in both the home and institutional settings used as a non-invasive therapeutic method to:

• Prevent deep vein thrombosis and resulting pulmonary embolism

• Intra-operative compression therapy

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/K031559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031559: Renu Medical Reporcessed Compressible Limb Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031559

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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