510(k) Report

510(k) · Cleared

Cleared

Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model SQS

K122873510(k) SpecialCleared Jan 15, 2013118-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

Caremed Supply, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Jan 15, 2013 as substantially equivalent to K110977 (Caremed Supply, Inc., 2011) after a 118-day review. Its family tree reaches back 3 generations to 1996.

Decided
Jan 15, 2013
Review
118 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K953648 (1996). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1999: 1 other ancestorK953648 · A-V Impulse System Model 6060 · Novamedix, Ltd. · 1996K040511 · SCD Express Portable Compression System · Tyco Healthcare/Kendall · 2004K110977 · Vesoflow · Caremed Supply, Inc. · 201119952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor K110977 · Vesoflow · Caremed Supply, Inc. · 2011K040511 · SCD Express Portable Compression System · Tyco Healthcare/Kendall · 2004K953648 · A-V Impulse System Model 6060 · Novamedix, Ltd. · 19960
  1. Root · 3 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
  2. 2 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
  3. 1 generation backK110977 VesoflowCaremed Supply, Inc. · 2011
  4. This deviceK122873 Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model…Caremed Supply, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953648A-V Impulse System Model 6060Novamedix, Ltd.1996—
−2K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall2004—
−1K110977VesoflowCaremed Supply, Inc.2011—
0 (this device)K122873Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model SQSCaremed Supply, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
FIG. 1 — Lineage of K122873, 1996–2013Source: 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
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What was it cleared against? (1)

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
*K110977Vesoflow
Summary page 1
…te Device: Predicate Device Name: VESOFLOW Manufacturer: CAREMED SUPPLY INC. Product Code: JOW 510(k) Number: K110977 17 Caremed Suppl…
Caremed Supply, Inc.2011—

Also cleared against K110977: 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 17 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 1 other device also cites its predicate K110977.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Caremed Supply Inc. VASOPOUSE® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K122873: Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model SQS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122873

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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