510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Reprocessed Compression Sleeves

K100909510(k) TraditionalCleared Jul 23, 2010113-day reviewClass II21 CFR 870.5800Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ascent Healthcare Solutions · JOW Sleeve, Limb, Compressible

Cleared on Jul 23, 2010 as substantially equivalent to K060049 (Alliance Medical Corp., 2006) and 8 other predicates after a 113-day review. Its family tree reaches back 4 generations to 1988. It has been recalled once.

Decided
Jul 23, 2010
Review
113 days
Class
Class II
Product code
JOW
Recalls
1
Predicates
9

Its longest line of descent runs back 4 generations to K881632 (1988). 30 ancestors in all, the oldest K781357 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 3 other ancestors2003: 3 other ancestors2001: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestors1999: 2 other ancestors1997: 1 other ancestor1996: 4 other ancestors1995: 2 other ancestors1993: 2 other ancestors1992: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1978: 1 other ancestorK881632 · 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 · 1998K012403 · Vanguard Reprocessed Compression Garment · Vanguard Medical Concepts, Inc. · 2001 · recalledK051438 · Vanguard Reprocessed Compression Garments (Hill-Rom) · Alliance Medical, Inc. · 2006 · recalled1980199020002010
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 18 other ancestors3 generations back: 1 other ancestor K051438 · Vanguard Reprocessed Compression Garments (Hill-Rom) · Alliance Medical, Inc. · 2006 · recalledK012403 · Vanguard Reprocessed Compression Garment · Vanguard Medical Concepts, Inc. · 2001 · recalledK974318 · 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 · 4 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
  2. 3 generations backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
  3. 2 generations backK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · Recalled
  4. 1 generation backK051438 Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · Recalled
  5. This deviceK100909 Reprocessed Compression SleevesAscent Healthcare Solutions · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K881632Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc.1988—
−3K974318Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…Healthcare Service and Supply1998—
−2K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20016
−1K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc.20061
0 (this device)K100909Reprocessed Compression SleevesAscent Healthcare Solutions2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198610
198910
199210
199320
199520
199640
199710
199920
200020
200110
200210
200330
200410
200630
FIG. 1 — Lineage of K100909, 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? (9)

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
*K060049Reprocessed Compression Sleeves
Summary page 1
…: Compression Sleeve Classification Name: Compressible Limb Sleeve Predicate Devices 51 0(k) Title Reprocessor K060049 Reprocessed Compression Sleeves Alliance Medical…
Alliance Medical Corp.2006—
*K060091Alliance Medical Corporation Reprocessed Compression Sleeves
Summary page 1
…cessor K060049 Reprocessed Compression Sleeves Alliance Medical Corporation K060091 Reprocessed Compression Sleeves Alliance Medical…
Alliance Medical Corp.2006—
*K053316Reprocessed Compression Sleeves
Summary page 1
…ration K060091 Reprocessed Compression Sleeves Alliance Medical Corporation K053316 Vanguard Reprocessed Vanguard Medical Compression Garments…
Alliance Medical Corp.2006—
*K051438Vanguard Reprocessed Compression Garments (Hill-Rom)
Summary page 1
…rporation K053316 Vanguard Reprocessed Vanguard Medical Compression Garments Concepts K051438 Vanguard Reprocessed Vanguard Medical Compression Garments (Hill-Ro…
Alliance Medical, Inc.20061
*K012403Vanguard Reprocessed Compression Garment
Summary page 1
…Concepts K051438 Vanguard Reprocessed Vanguard Medical Compression Garments (Hill-Rom) Concepts K012403 Vanguard Reprocessed Vanguard Medical Compression Garments…
Vanguard Medical Concepts, Inc.20016
*K024087Reprocessed Compression Sleeves
Summary page 1
…Concepts K012403 Vanguard Reprocessed Vanguard Medical Compression Garments Concepts K024087 Reprocessed Compression Sleeves Alliance Medical…
Alliance Medical Corp.2003—
*K024074Reprocessed Compression Sleeves
Summary page 1
…ncepts K024087 Reprocessed Compression Sleeves Alliance Medical Corporation K024074 Reprocessed Compression Sleeves Alliance Medical…
Alliance Medical Corp.2003—
*K021654Reprocessed Compression Sleeve
Summary page 1
…ration K024074 Reprocessed Compression Sleeves Alliance Medical Corporation K021654 Reprocessed Compression Sleeves Alliance Medical…
Alliance Medical, Inc.2003—
*K011192Compressible Limb Sleeve
Summary page 1
…ration K021654 Reprocessed Compression Sleeves Alliance Medical Corporation K011192 Reprocessed Compression Sleeves Alliance Medical…
Alliance Medical Corp.2001—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 14, 2023Class IIZ-1612-2023Under Investigation by firmThrough complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
  • 5 of the 30 ancestors have a recall of any class.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Indications for use as stated in the FDA summary.

More from Ascent Healthcare Solutions

21 FDA decisions under this applicant name. See the company

  • K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions · 2011
  • K110189Reprocessed Electrosurgical InstrumentAscent Healthcare Solutions · 2011
  • K100254Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions · 201027 recalls
  • K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, GablueAscent Healthcare Solutions · 2010
  • K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 20101 recall

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/K100909 · printed Nov 5, 2026

Cite this page

510(k) Report. “K100909: Reprocessed Compression Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100909

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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