510(k) Report

510(k) · Cleared

Cleared

Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480

K012417510(k) TraditionalCleared Apr 8, 2002252-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

Hygia Health Services, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Apr 8, 2002 after a 252-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
Apr 8, 2002
Review
252 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
0

9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2003: 1 descendant cleared2006: 2 descendants cleared2010: 3 descendants cleared2021: 1 descendant cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK012417 Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329…Hygia Health Services, Inc. · 2002
  2. Descendant · cites it directly · 4 of its ownK031559 Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003
  3. Descendant · cites it directly · 3 of its ownK053575 Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot…Hygia Health Services, Inc. · 2006
  4. Descendant · 2 generations on · 2 of its ownK051227 Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006
  5. Descendant · cites it directly · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
  6. Descendant · 2 generations on · 0 of its ownK203847 Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 12006: 22008: 12009: 12010: 32021: 1
2003high 3 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 9 · See all
  • K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003 · cites it directly4descendants
  • K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc. · 2006 · cites it directly3descendants
  • K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006 · 2 generations on2descendants
  • K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
  • K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012417Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330…Hygia Health Services, Inc.2002—
+1K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc.2003—
+1K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.2006—
+2K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc.2006—
+1K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.2009—
+2K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200620
200810
200910
201030
202110
FIG. 1 — Lineage of K012417, 2002–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Kendall SCD™ Sleeve
Named without a submission number
—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc.20034
K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.20063
K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.20091
K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100

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?

  • Of its descendants, K031559 (Renu Medical, Inc., 2003) has gone furthest, with 4 descendants of its own.

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

2007: 62008: 42009: 32010: 182011: 112012: 132013: 172014: 162015: 102016: 92017: 92018: 112019: 112020: 142021: 162022: 72023: 62024: 82025: 72026 (partial year): 6
2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007: 66 days median2008: 112 days median2009: 84 days median2010: 71 days median2011: 104 days median2012: 63 days median2013: 94 days median2014: 91 days median2015: 160 days median2016: 121 days median2017: 116 days median2018: 136 days median2019: 88 days median2020: 158 days median2021: 132 days median2022: 80 days median2023: 160 days median2024: 197 days median2025: 168 days median2026 (partial year): 252 days median
2007high 252 (2026) · low 63 (2012)2026

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

Recalls per year · JOW

1in 2019

2008: 72010: 22011: 32012: 22017: 12019: 1
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

2007: 122008: 362009: 452010: 662011: 502012: 1002013: 1692014: 932015: 1372016: 1502017: 1492018: 1142019: 1022020: 502021: 342022: 272023: 572024: 302025: 24
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007666012
20084112736
2009384045
20101871266
201111104350
201213632100
201317940169
20141691093
2015101600137
201691210150
201791161149
2018111360114
201911881102
202014158050
202116132034
2022780027
20236160057
20248197030
20257168024
202662520—

What is it indicated for?

The Hygia Health Services Reprocessed Kendall SCD™ Sleeve is used in the treatment

of venous leg ulcers and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Kendall SCD™ Sleeve is also a non-invasive

therapeutic method for prevention of deep vein thrombosis.

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

More from Hygia Health Services, Inc.

14 FDA decisions under this applicant name. See the company

  • K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM…Hygia Health Services, Inc. · 2010
  • K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
  • K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and HHS-1861Hygia Health Services, Inc. · 2008
  • K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc. · 2006
  • K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc. · 2004

Recent decisions in JOW

The JOW category page

  • K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
  • K254217AerloomEvolym, LLC · 2026
  • K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
  • K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
  • K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K012417 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012417: Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012417

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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