510(k) Report

510(k) · Cleared

Cleared

ANGIO-PRESS LITE DVT Compression Device

K173012510(k) TraditionalCleared May 10, 2018225-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

Pegasus Medical Supply, Inc. · JOW Sleeve, Limb, Compressible

Cleared on May 10, 2018 as substantially equivalent to K143202 (Pegasus Medical Supply, Inc., 2015) after a 225-day review. Its family tree reaches back 2 generations to 2010.

Decided
May 10, 2018
Review
225 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K101915 (2010). No later device cites it as a predicate yet.

  1. Root · 2 generations backK101915 Vasopress Supreme Mini Model VP500DMCompression Therapy Concepts, Inc. · 2010
  2. 1 generation backK143202 ANGIO-PRESS DVT Compression Device Model Name: IPCSPegasus Medical Supply, Inc. · 2015
  3. This deviceK173012 ANGIO-PRESS LITE DVT Compression DevicePegasus Medical Supply, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K101915Vasopress Supreme Mini Model VP500DMCompression Therapy Concepts, Inc.2010—
−1K143202ANGIO-PRESS DVT Compression Device Model Name: IPCSPegasus Medical Supply, Inc.2015—
0 (this device)K173012ANGIO-PRESS LITE DVT Compression DevicePegasus Medical Supply, Inc.2018—
FIG. 1 — Lineage of K173012, 2010–2018Source: 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
*K143202ANGIO-PRESS DVT Compression Device Model Name: IPCS
Summary page 4
…ion Product Code: Regulation number: Device Class: 510(k) Number: ANGIO-PRESS DVT Compression Device Model Name: IPCS Pegasus Medical Supply, Inc. JOW 870.5800 II K143202 2/7 Pegasus Medical Supply, Inc. Traditional 510(k), K173012/S003 ANGIO-PRESS LITE DVT Compression Device Sectio…
Pegasus Medical Supply, Inc.2015—

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 8 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

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

Cite this page

510(k) Report. “K173012: ANGIO-PRESS LITE DVT Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173012

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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