510(k) Report

510(k) · Cleared

Cleared

Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb

K974318510(k) TraditionalCleared Feb 13, 199888-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

Healthcare Service and Supply · JOW Sleeve, Limb, Compressible

Cleared on Feb 13, 1998 as substantially equivalent to K955853 (Healthcare Service and Supply, 1996) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1988. 8 later devices descend from it.

Decided
Feb 13, 1998
Review
88 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K881632 (1988). 2 ancestors in all. 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2009: 1 descendant cleared2006: 3 descendants cleared2001: 1 descendant cleared2010: 3 descendants clearedK881632 · Flowtron DVT System AC500 Pump, L501 Garment · Huntleigh Technology, Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants K881632 · Flowtron DVT System AC500 Pump, L501 Garment · Huntleigh Technology, Inc. · 19880
  1. Root · 1 generation backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
  2. This deviceK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
  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 · cites it directly · 3 of its ownK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · Recalled
  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 · 1 of its ownK051438 Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · Recalled
  7. Descendant · cites it directly · 0 of its ownK101330 Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot…Midwest Reprocessing Center, LLC · 2010

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2001: 12006: 32009: 12010: 3
2001high 3 (2006) · low 0 (2002)2026

Most influential descendants

Showing 5 of 8 · See all
  • K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc. · 2006 · cites it directly3descendants
  • K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · cites it directly3descendants
  • K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
  • K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · 2 generations on1descendant
  • K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K881632Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc.1988—
0 (this device)K974318Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…Healthcare Service and Supply1998—
+1K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.2006—
+1K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20016
+1K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.2009—
+2K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc.20061
+1K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs…Midwest Reprocessing Center, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200630
200910
201030
FIG. 1 — Lineage of K974318, 1988–2010Source: 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? (2)

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
*K955853Healthcare Service & Supply Pump Alp 501 Pump System
Summary page 1
…are substantially equivalent to devices in commercial distribution by the following companies: . Healthcare Service and Supply ALP® 501 Pump System, Tustin, CA 992681; K955853 . Huntleigh Technology DVT System AC500, L501 Garment, Manalapan, NJ, 07726; K881632 IV. DESCRIPTION The ALP consists of an el…
Healthcare Service and Supply1996—
*K881632Flowtron DVT System AC500 Pump, L501 Garment
Summary page 1
…ompanies: . Healthcare Service and Supply ALP® 501 Pump System, Tustin, CA 992681; K955853 . Huntleigh Technology DVT System AC500, L501 Garment, Manalapan, NJ, 07726; K881632 IV. DESCRIPTION The ALP consists of an electrically-operated pump and controller with inflatable limb garments (or limb compres…
Huntleigh Technology, Inc.1988—

Also cleared against K955853: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.20063
K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20013
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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K053575 (Hygia Health Services, Inc., 2006) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K955853.

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 Healthcare Service and Supply ALP® 501 Pump and Limb Garments are recommended for use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE SYSTEM® (ALP® is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

The Healthcare Service and Supply garments are attachable to the ALP® Pump as well as to the Huntleigh Flowtron® pump.

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

Also cleared against K955853

3 other devices cite the same predicate.

  • K143317Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)Currie Medical Specialties, Inc. · 2015
  • K140092Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes)Currie Medical Specialties, Inc. · 2014
  • K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 20016 recalls

More from Healthcare Service and Supply

4 FDA decisions under this applicant name. See the company

  • K000303Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the LimbHealthcare Service and Supply · 2000
  • K964188Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot GarmentHealthcare Service and Supply · 1997
  • K955853Healthcare Service & Supply Pump Alp 501 Pump SystemHealthcare Service and Supply · 1996

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/K974318 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974318: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974318

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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