510(k) Report

510(k) · Cleared

Recalled · 2010

A-V Impulse System Model 6060

K951683510(k) TraditionalCleared Oct 26, 1995198-day reviewClass II21 CFR 870.5800Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novamedix, Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Oct 26, 1995 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled 2 times.

Decided
Oct 26, 1995
Review
198 days
Class
Class II
Product code
JOW
Recalls
2
Predicates
0

21 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared2010: 2 descendants cleared2013: 1 descendant cleared2025: 3 descendants cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 4 descendants cleared2024: 3 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951683 A-V Impulse System Model 6060Novamedix, Ltd. · 1995
  2. Descendant · cites it directly · 18 of its ownK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
  3. Descendant · 2 generations on · 14 of its ownK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
  4. Descendant · 3 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
  5. Descendant · 4 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
  6. Descendant · 4 generations on · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002: 12006: 12007: 12010: 22011: 12013: 12018: 12019: 12020: 12023: 42024: 32025: 32026: 1
2002high 4 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 21 · See all
  • K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007 · cites it directly18descendants
  • K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013 · 2 generations on14descendants
  • K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 3 generations on12descendants
  • K190854Therm-XZenith Technical Innovations · 2019 · 4 generations on11descendants
  • K193550Therm-XZenith Technical Innovations · 2020 · 4 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951683A-V Impulse System Model 6060Novamedix, Ltd.1995—
+1K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.2007—
+2K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.2013—
+3K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations2018—
+4K190854Therm-XZenith Technical Innovations2019—
+4K193550Therm-XZenith Technical Innovations2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
200710
201020
201110
201310
201810
201910
202010
202340
202430
202530
202610
FIG. 1 — Lineage of K951683, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.200718
K012597Sterilmed Reprocessed Compression SleevesSterilmed, Inc.20021

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 11, 2010Not classifiedZ-2656-2010Release of Material/Component prior to receiving test resultsCovidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to…
Aug 11, 2010Not classifiedZ-2657-2010Release of Material/Component prior to receiving test resultsCovidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K072666 (Bio Compression Systems, Inc., 2007) has gone furthest, with 18 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—

More from Novamedix, Ltd.

3 FDA decisions under this applicant name. See the company

  • K953648A-V Impulse System Model 6060Novamedix, Ltd. · 1996
  • K914461A-V Impulse SystemNovamedix, Ltd. · 1992

Recent decisions in JOW

The JOW category page

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  • 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/K951683 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951683: A-V Impulse System Model 6060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951683

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026