510(k) Report

510(k) · Cleared

Cleared

Flowtron DVT System AC500 Pump, L501 Garment

K881632510(k) TraditionalCleared Sep 26, 1988165-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

Huntleigh Technology, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Sep 26, 1988 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.

Decided
Sep 26, 1988
Review
165 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
0

37 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared1998: 2 descendants cleared2010: 6 descendants cleared2006: 4 descendants cleared2001: 1 descendant cleared1999: 1 descendant cleared2007: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2018: 2 descendants cleared2025: 3 descendants cleared2024: 4 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 4 descendants cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
  2. Descendant · cites it directly · 22 of its ownK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
  3. Descendant · 2 generations on · 18 of its ownK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
  4. Descendant · 3 generations on · 14 of its ownK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
  5. Descendant · 4 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
  6. Descendant · 5 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1998: 21999: 12001: 12004: 22006: 42007: 12009: 12010: 62011: 12013: 22018: 22019: 12020: 12023: 42024: 42025: 32026: 1
1998high 6 (2010) · low 0 (2000)2026

Most influential descendants

Showing 5 of 37 · See all
  • K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006 · cites it directly22descendants
  • K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007 · 2 generations on18descendants
  • K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013 · 3 generations on14descendants
  • K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 4 generations on12descendants
  • K190854Therm-XZenith Technical Innovations · 2019 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881632Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc.1988—
+1K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc.2006—
+2K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.2007—
+3K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.2013—
+4K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations2018—
+5K190854Therm-XZenith Technical Innovations2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200110
200420
200640
200710
200910
201060
201110
201320
201820
201910
202010
202340
202440
202530
202610
FIG. 1 — Lineage of K881632, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc.200622
K974318Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the LimbHealthcare Service and Supply19988
K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20013
K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC20100
K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100
K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100
K040065Jsa's Reprocessed Compression Sleeve DevicesJack Speer and Assoc., Inc.20040
K033615Wfsi's Reprocessed Compression Sleeve DevicesWheaton Franciscan Services Inc., Supply Chain20040
K983680Trinity II Single Chamber DVT PumpDelphi Consulting Group19990
K981643RTM DVT Prosoft Cuff Model Number PS100R.T. Medical Services, Inc.19980

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, K061857 (Bio Compression Systems, Inc., 2006) has gone furthest, with 22 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 Huntleigh Technology, Inc.

23 FDA decisions under this applicant name. See the company

  • K992733Akron ATP9 Traction MachineHuntleigh Technology, Inc. · 1999
  • K964699Rheo Dopplex II (RD 2)Huntleigh Technology, Inc. · 1997
  • K924516OP3/VP4Huntleigh Technology, Inc. · 1993
  • K910188Flowplus AC330 Pump GarmentsHuntleigh Technology, Inc. · 1991
  • K900882Multi Dopplex, MD-1Huntleigh Technology, Inc. · 1990

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/K881632 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881632: Flowtron DVT System AC500 Pump, L501 Garment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881632

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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