510(k) Report

510(k) · Cleared

Cleared

Vascucomp

K103247510(k) TraditionalCleared Dec 10, 201037-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

Thermotek, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Dec 10, 2010 as substantially equivalent to K072666 (Bio Compression Systems, Inc., 2007) and 2 other predicates after a 37-day review. Its family tree reaches back 3 generations to 1995.

Decided
Dec 10, 2010
Review
37 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K944567 (1995). 18 ancestors in all, the oldest K881632 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2005: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1995: 2 other ancestors1992: 1 other ancestor1998: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestorK944567 · Cowboy X · Kinetic Concepts, Inc. · 1995 · recalledK981311 · Cowboy XV · Kci New Technologies, Inc. · 1999K061866 · Nanotherm, Vascutherm and Prothermo Therapy Wraps · Thermotek, Inc. · 2006198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 3 other ancestors K061866 · Nanotherm, Vascutherm and Prothermo Therapy Wraps · Thermotek, Inc. · 2006K981311 · Cowboy XV · Kci New Technologies, Inc. · 1999K944567 · Cowboy X · Kinetic Concepts, Inc. · 1995 · recalled0
  1. Root · 3 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
  2. 2 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
  3. 1 generation backK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
  4. This deviceK103247 VascucompThermotek, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K944567Cowboy XKinetic Concepts, Inc.19951
−2K981311Cowboy XVKci New Technologies, Inc.1999—
−1K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.2006—
0 (this device)K103247VascucompThermotek, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199210
199310
199520
199620
199710
199810
200110
200310
200510
200620
200710
FIG. 1 — Lineage of K103247, 1995–2010Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K072666Bioarterial Plus, Arterial Blood Flow Enhancement System
Summary page 1
…Cardiovascular IDENTIFICATrION OF PREDICATE DEVICES [As Required by 21 CER 807.92 a(3)] RioCompression Systems, Inc., BioArterial Plus K072666 ThermoTek Inc., VaseuThenn K061 866 PBS (Petit Basci System) Model 701A K06022…
Bio Compression Systems, Inc.2007—
*K061866Nanotherm, Vascutherm and Prothermo Therapy Wraps
Summary page 1
…TE DEVICES [As Required by 21 CER 807.92 a(3)] RioCompression Systems, Inc., BioArterial Plus K072666 ThermoTek Inc., VaseuThenn K061 866 PBS (Petit Basci System) Model 701A K060220 6…
Thermotek, Inc.2006—
*K060220PBS Model 701A Compression Therapy Device
Summary page 1
…tems, Inc., BioArterial Plus K072666 ThermoTek Inc., VaseuThenn K061 866 PBS (Petit Basci System) Model 701A K060220 6 DEVICE DESCRIPTION [As Required by 21 CFR 807.92 a(4)] Intended…
Mego Afek2006—

Also cleared against K072666: 3 other devices →

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 15 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
  • 2 of the 18 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K072666.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 VascuComp™ compression system in AI Mode is used as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: * Minor Amputations * Angioplasty / Stent Failure * Arteriopathic Wounds * Graft Failure * Intermittent Claudication * Ischemia * Night Pain * Rest Pain * Small Vessel Disease * Ulcers * Decrease the risk of deep venous thrombosis (DVT). * Aids the blood flow back to the heart.…

Read the full statement (122 words)

The VascuComp™ compression system in AI Mode is used as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

* Minor Amputations

* Angioplasty / Stent Failure

* Arteriopathic Wounds

* Graft Failure

* Intermittent Claudication

* Ischemia

* Night Pain

* Rest Pain

* Small Vessel Disease

* Ulcers

* Decrease the risk of deep venous thrombosis (DVT).

* Aids the blood flow back to the heart.

* Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

*Treatment of Venous disorders and dysfunction of the "muscle pump"

Indications for use as stated in the FDA summary.

Also cleared against K072666

3 other devices cite the same predicate.

  • K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
  • K111748Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long · 2011
  • K102582Arterioflow Model 7500 Sequential Compression DeviceDevon Medical, Inc. · 2010

More from Thermotek, Inc.

4 FDA decisions under this applicant name. See the company

  • K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
  • K945853Thermotek H-300Thermotek, Inc. · 1995
  • K950711T-350 Therapeutic Cooling MachineThermotek, Inc. · 1995

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/K103247 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103247: Vascucomp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103247

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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