510(k) Report

510(k) · Cleared

Cleared

Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs

K053575510(k) TraditionalCleared Feb 15, 200655-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 Feb 15, 2006 as substantially equivalent to K040511 (Tyco Healthcare/Kendall, 2004) and 6 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it.

Decided
Feb 15, 2006
Review
55 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K881632 (1988). 12 ancestors in all, the oldest K781357 (1978). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2002: 3 other ancestors2000: 1 other ancestor1999: 1 other ancestor1996: 2 other ancestors1978: 1 other ancestor2009: 1 descendant cleared2010: 2 descendants clearedK881632 · Flowtron DVT System AC500 Pump, L501 Garment · Huntleigh Technology, Inc. · 1988K974318 · Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb · Healthcare Service and Supply · 199819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K974318 · Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb · Healthcare Service and Supply · 1998K881632 · Flowtron DVT System AC500 Pump, L501 Garment · Huntleigh Technology, Inc. · 19880
  1. Root · 2 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
  2. 1 generation backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
  3. This deviceK053575 Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot…Hygia Health Services, Inc. · 2006
  4. Descendant · cites it directly · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK101330 Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot…Midwest Reprocessing Center, LLC · 2010
  6. Descendant · 2 generations on · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
  • K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
  • K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K881632Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc.1988—
−1K974318Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…Healthcare Service and Supply1998—
0 (this device)K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.2006—
+1K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.2009—
+1K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs…Midwest Reprocessing Center, LLC2010—
+2K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199620
199910
200010
200230
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
FIG. 1 — Lineage of K053575, 1988–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (7)

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
*K040511SCD Express Portable Compression System
Summary page 1
…althcare Service and Supply Sleeves/Foot Cuffs legally marketed under various 510(k) premarket notifications: Tyco Healthcare/Kendall K040511 Tyco Healthcare/Kendall K040649 Healthcare Service and K974318…
Tyco Healthcare/Kendall2004—
*K040649Kendall SCD Express Kambia Thigh Length Tearaway Sleeve
Summary page 1
…lly marketed under various 510(k) premarket notifications: Tyco Healthcare/Kendall K040511 Tyco Healthcare/Kendall K040649 Healthcare Service and K974318 Supply Aircast, Inc.…
Tyco Healthcare2004—
*K974318Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb
Summary page 1
…Tyco Healthcare/Kendall K040511 Tyco Healthcare/Kendall K040649 Healthcare Service and K974318 Supply Aircast, Inc. K992454 Previous Hygia Health Servic…
Healthcare Service and Supply1998—
*K992454Venaflow System, Model 30A
Summary page 1
…althcare/Kendall K040649 Healthcare Service and K974318 Supply Aircast, Inc. K992454 Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent: HHS Reproc…
Aircast, Inc.2000—
*K012417Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480
Summary page 1
…992454 Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent: HHS Reprocessed Kendall SCDTM Sleeves K012417 26 HI-S Reprocessed Huntleigh Flowtron® K0126…
Hygia Health Services, Inc.2002—
*K012654Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20…
Summary page 2
…processed Kendall SCDTM Sleeves K012417 26 HI-S Reprocessed Huntleigh Flowtron® K012654 HHS Reprocessed Novamedix Impad® K021509 4. Device Description The Hygia Health Serv…
Hygia Health Services, Inc.2002—
*K021509Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089
Summary page 2
…26 HI-S Reprocessed Huntleigh Flowtron® K012654 HHS Reprocessed Novamedix Impad® K021509 4. Device Description The Hygia Health Services reprocessed sleeves/foot garments are compression…
Hygia Health Services, Inc.2002—

Also cleared against K040511: 8 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
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?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K090074 (Hygia Health Services, Inc., 2009) has gone furthest, with 1 descendant of its own.
  • 8 other devices also cite its predicate K040511.

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 Aircast Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

Indications for use as stated in the FDA summary.

Also cleared against K040511

8 other devices cite the same predicate.

  • K163055Reprocessed Kendall SCD Express Foot CuffCovidien · 2016
  • K112677The Venous Assist SystemDaesung Maref Co., Ltd. · 2012
  • K110977VesoflowCaremed Supply, Inc. · 2011
  • K110358Venodyne V810Microtek Medical, Inc. · 2011
  • K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010
  • K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center…Midwest Reprocessing Center, LLC · 2010

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
  • K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc. · 2004
  • K032821Hygia Health Services Reprocessed Blood Pressure CuffHygia Health Services, Inc. · 2003

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/K053575 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053575

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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