510(k) Report

510(k) · Cleared

Cleared

Kendall Model 7325 SCD Response Compression System, Model 7325

K992079510(k) SpecialCleared Sep 29, 1999100-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

The Kendall Company, L.P. · JOW Sleeve, Limb, Compressible

Cleared on Sep 29, 1999 after a 100-day review. The FDA summary names its predicate without a number. 42 later devices descend from it.

Decided
Sep 29, 1999
Review
100 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
0

42 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2001: 1 descendant cleared2006: 4 descendants cleared2010: 5 descendants cleared2011: 2 descendants cleared2012: 3 descendants cleared2016: 4 descendants cleared2009: 1 descendant cleared2014: 3 descendants cleared2013: 4 descendants cleared2021: 3 descendants cleared2020: 3 descendants cleared2025: 2 descendants cleared2022: 2 descendants cleared2026: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992079 Kendall Model 7325 SCD Response Compression System, Model 7325The Kendall Company, L.P. · 1999
  2. Descendant · cites it directly · 38 of its ownK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
  3. Descendant · 2 generations on · 11 of its ownK102737 Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010
  4. Descendant · 2 generations on · 10 of its ownK112677 The Venous Assist SystemDaesung Maref Co., Ltd. · 2012
  5. Descendant · 2 generations on · 6 of its ownK110977 VesoflowCaremed Supply, Inc. · 2011
  6. Descendant · 3 generations on · 5 of its ownK120944 Kendall SCD 700 Sequential Compression ControllerCovidien · 2012

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12006: 42009: 12010: 52011: 22012: 32013: 42014: 32015: 12016: 42018: 12020: 32021: 32022: 22023: 12025: 22026: 1
2001high 5 (2010) · low 0 (2002)2026

Most influential descendants

Showing 5 of 42 · See all
  • K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004 · cites it directly38descendants
  • K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010 · 2 generations on11descendants
  • K112677The Venous Assist SystemDaesung Maref Co., Ltd. · 2012 · 2 generations on10descendants
  • K110977VesoflowCaremed Supply, Inc. · 2011 · 2 generations on6descendants
  • K120944Kendall SCD 700 Sequential Compression ControllerCovidien · 2012 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992079Kendall Model 7325 SCD Response Compression System, Model 7325The Kendall Company, L.P.1999—
+1K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall2004—
+2K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC2010—
+2K112677The Venous Assist SystemDaesung Maref Co., Ltd.2012—
+2K110977VesoflowCaremed Supply, Inc.2011—
+3K120944Kendall SCD 700 Sequential Compression ControllerCovidien2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200640
200910
201050
201120
201230
201340
201430
201510
201640
201810
202030
202130
202220
202310
202520
202610
FIG. 1 — Lineage of K992079, 1999–2026Source: 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
*—Kendall SCD Sequel™ Compression System
Named without a submission number
—

What descends from it? (42)

See all 42

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall200438
K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20013
K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060

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?

  • Of its descendants, K040511 (Tyco Healthcare/Kendall, 2004) has gone furthest, with 38 descendants of its own.

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?

The SCD RESPONSE Compression System is designed to apply sequential compression to the lower Limbs to help prevent deep vein thrombosis in patients at risk.

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. “K992079: Kendall Model 7325 SCD Response Compression System, Model 7325.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992079

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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