510(k) Report

510(k) · Cleared

Cleared

Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments (Sterile)

K122179510(k) SpecialCleared Aug 20, 201228-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

Compression Therapy Concepts · JOW Sleeve, Limb, Compressible

Cleared on Aug 20, 2012 as substantially equivalent to K991038 (Britt Corp., Inc., 2000) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 2000.

Decided
Aug 20, 2012
Review
28 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K991038 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK991038 · Vaso Press DVT System, Models VP500, VP501 · Britt Corp., Inc. · 2000K112838 · Vasopress Reprocessed DVT Leg / Foot Garments · Compression Therapy Concepts, Inc. · 201120002002200420062008201020122014
Other ancestors, by generation 1 generation back: 1 other ancestor K112838 · Vasopress Reprocessed DVT Leg / Foot Garments · Compression Therapy Concepts, Inc. · 2011K991038 · Vaso Press DVT System, Models VP500, VP501 · Britt Corp., Inc. · 20000
  1. Root · 2 generations backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
  2. 1 generation backK112838 Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc. · 2011
  3. This deviceK122179 Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments…Compression Therapy Concepts · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K991038Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc.2000—
−1K112838Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc.2011—
0 (this device)K122179Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments (Sterile)Compression Therapy Concepts2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K122179, 2000–2012Source: 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? (3)

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
*K991038Vaso Press DVT System, Models VP500, VP501
Summary page 1
…in commercial distribution by Compression Therapy Concepts, Inc., 555 Industrial Way West, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038, K1 12838) and VasoPress DVT Foot Garments VP 520 (K003828, K1 12838). Device Description: The VasoPress DVT Leg Garment…
Britt Corp., Inc.2000—
*K112838Vasopress Reprocessed DVT Leg / Foot Garments
Summary page 1
…cial distribution by Compression Therapy Concepts, Inc., 555 Industrial Way West, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038, K1 12838) and VasoPress DVT Foot Garments VP 520 (K003828, K1 12838). Device Description: The VasoPress DVT Leg Garment (sterile)…
Compression Therapy Concepts, Inc.2011—
*K003828Vaso Press DVT Foot Garment #VP 520
Summary page 1
…c., 555 Industrial Way West, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038, K1 12838) and VasoPress DVT Foot Garments VP 520 (K003828, K1 12838). Device Description: The VasoPress DVT Leg Garment (sterile) consists of a brushed nylon outer material bonde…
Britt Corp., Inc.2001—

Also cleared against K991038: 3 other devices →

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 12 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
  • None of the 3 ancestors has a recall.
  • 3 other devices also cite its predicate K991038.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DV-r) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.

Indications for use as stated in the FDA summary.

Also cleared against K991038

3 other devices cite the same predicate.

  • K130571Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
  • K112838Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc. · 2011
  • K090308Restep Dvy System, Model RSP-101Stortford Medical, LLC · 20091 recall

More from Compression Therapy Concepts

3 FDA decisions under this applicant name. See the company

  • K102940Vascopress Sequential DVT PumpCompression Therapy Concepts · 2011
  • K102732Vasograd DVT Compression GarmentCompression Therapy Concepts · 2010

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/K122179 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122179: Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122179

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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