510(k) Report

510(k) · Cleared

Cleared

Suretek Medical Reprocessed Compression Sleeves

K052691510(k) TraditionalCleared May 17, 2006231-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

Suretek Medical · JOW Sleeve, Limb, Compressible

Cleared on May 17, 2006 as substantially equivalent to K022786 (Huntleigh Healthcare, Inc., 2002) and 11 other predicates after a 231-day review. Its family tree reaches back 3 generations to 1988.

Decided
May 17, 2006
Review
231 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
12

Its longest line of descent runs back 3 generations to K881632 (1988). 28 ancestors in all, the oldest K781357 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 3 other ancestors2001: 1 other ancestor2000: 2 other ancestors1999: 2 other ancestors1997: 2 other ancestors1996: 4 other ancestors1995: 3 other ancestors1993: 3 other ancestors1991: 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 · recalled1975198019851990199520002005
Other ancestors, by generation 1 generation back: 11 other ancestors2 generations back: 14 other ancestors K012403 · 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 · 3 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
  2. 2 generations backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
  3. 1 generation backK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · Recalled
  4. This deviceK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881632Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc.1988—
−2K974318Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…Healthcare Service and Supply1998—
−1K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20016
0 (this device)K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198610
198910
199110
199330
199530
199640
199720
199920
200020
200110
200230
200310
FIG. 1 — Lineage of K052691, 1988–2006Source: 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? (12)

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
*K022786DVT60
Summary page 1
…turer/Reprocessor Tradename(s) 510(k)'s Devices Huntleigh Healthcare Flowtron* K022786, K010744 Kendall (Tyco Healthcare) SCD*, Impad* K992079, K964425…
Huntleigh Healthcare, Inc.2002—
*K010744Flowtron Universal, Model AC600
Summary page 1
…rocessor Tradename(s) 510(k)'s Devices Huntleigh Healthcare Flowtron* K022786, K010744 Kendall (Tyco Healthcare) SCD*, Impad* K992079, K964425…
Huntleigh Healthcare, Inc.20021
*K992079Kendall Model 7325 SCD Response Compression System, Model 7325
Summary page 1
…hcare Flowtron* K022786, K010744 Kendall (Tyco Healthcare) SCD*, Impad* K992079, K964425 Kinetic Concepts Plexipulse* K981311…
The Kendall Company, L.P.1999—
*K964425A-V Impulse System Model 6060
Summary page 1
…Flowtron* K022786, K010744 Kendall (Tyco Healthcare) SCD*, Impad* K992079, K964425 Kinetic Concepts Plexipulse* K981311 Comp…
Powell,Goldstein,Frazer & Murphy1997—
*K981311Cowboy XV
Summary page 1
…ealthcare) SCD*, Impad* K992079, K964425 Kinetic Concepts Plexipulse* K981311 Compression Therapy VasoPress* K003828 Curr…
Kci New Technologies, Inc.1999—
*K003828Vaso Press DVT Foot Garment #VP 520
Summary page 1
…c Concepts Plexipulse* K981311 Compression Therapy VasoPress* K003828 Currie Medical Alternating Leg Pressure, ALP* K000303 Airc…
Britt Corp., Inc.2001—
*K000303Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the Limb
Summary page 1
…ssion Therapy VasoPress* K003828 Currie Medical Alternating Leg Pressure, ALP* K000303 Aircast Venaflow* K992454, K023800…
Healthcare Service and Supply2000—
*K992454Venaflow System, Model 30A
Summary page 1
…Medical Alternating Leg Pressure, ALP* K000303 Aircast Venaflow* K992454, K023800 Alba Health pulStar* K961405…
Aircast, Inc.2000—
*K023800Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017
Summary page 1
…Alternating Leg Pressure, ALP* K000303 Aircast Venaflow* K992454, K023800 Alba Health pulStar* K961405 Ster…
Aircast, Inc.2003—
*K961405Alba Health Pas Wrap System
Summary page 1
…Venaflow* K992454, K023800 Alba Health pulStar* K961405 SterilMed Reprocessed Compression Sleeves K012597 Vang…
Alba-Waldensian, Inc.19961
*K012597Sterilmed Reprocessed Compression Sleeves
Summary page 1
…ealth pulStar* K961405 SterilMed Reprocessed Compression Sleeves K012597 Vanguard Medical Concepts Reprocessed Compression Garment K012403 Device Comp…
Sterilmed, Inc.2002—
*K012403Vanguard Reprocessed Compression Garment
Summary page 1
…Med Reprocessed Compression Sleeves K012597 Vanguard Medical Concepts Reprocessed Compression Garment K012403 Device Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf Design a…
Vanguard Medical Concepts, Inc.20016

Also cleared against K022786: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 4 companies; a new generation was cleared every 4.6 years on median.
  • 6 of the 28 ancestors have a recall of any class.
  • 1 other device also cites its predicate K022786.

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?

SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Indications for use as stated in the FDA summary.

Also cleared against K022786

1 other device cites the same predicate.

  • K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009

More from Suretek Medical

4 FDA decisions under this applicant name. See the company

  • K052690Suretek Reprocessed Laparoscopic InstrumentsSuretek Medical · 2006
  • K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical · 2006
  • K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006

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/K052691 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052691: Suretek Medical 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/K052691

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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