510(k) Report

510(k) · Cleared

Cleared

ALP VasQcare Take Home System

K151158510(k) TraditionalCleared Dec 10, 2015223-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

Currie Medical Specialties, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Dec 10, 2015 as substantially equivalent to K112311 (Currie Medical Specialties, Inc., 2011) and 2 other predicates after a 223-day review. Its family tree reaches back 5 generations to 1992.

Decided
Dec 10, 2015
Review
223 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K915638 (1992). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1996: 1 other ancestor2006: 1 other ancestor2000: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor1995: 2 other ancestorsK915638 · Talley TM200 Intermttent Compression Unit · Progressive Medical Technology, Inc. · 1992K022340 · Travelair Portable Compression System · Dynamic Air, Inc. · 2003K061125 · Dvtcare CA5 · Doctors Orders · 2006K103187 · Tripleplay-VT Vascular Therapy System · Wildcat Medical, Inc. · 2011K133274 · Vena Pro · Innovamed Health, LLC · 2014199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 5 other ancestors5 generations back: 1 other ancestor K133274 · Vena Pro · Innovamed Health, LLC · 2014K103187 · Tripleplay-VT Vascular Therapy System · Wildcat Medical, Inc. · 2011K061125 · Dvtcare CA5 · Doctors Orders · 2006K022340 · Travelair Portable Compression System · Dynamic Air, Inc. · 2003K915638 · Talley TM200 Intermttent Compression Unit · Progressive Medical Technology, Inc. · 1992−50
  1. Root · 5 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
  2. 4 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
  3. 3 generations backK061125 Dvtcare CA5Doctors Orders · 2006
  4. 2 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
  5. 1 generation backK133274 Vena ProInnovamed Health, LLC · 2014
  6. This deviceK151158 ALP VasQcare Take Home SystemCurrie Medical Specialties, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K915638Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc.1992—
−4K022340Travelair Portable Compression SystemDynamic Air, Inc.2003—
−3K061125Dvtcare CA5Doctors Orders2006—
−2K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.2011—
−1K133274Vena ProInnovamed Health, LLC2014—
0 (this device)K151158ALP VasQcare Take Home SystemCurrie Medical Specialties, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
199710
199910
200010
200110
200210
200310
200510
200610
201110
FIG. 1 — Lineage of K151158, 1992–2015Source: 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? (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
*K112311Alp 501 RB Pump System
Summary page 4
…Cardiovascular Regulation Number: 870.5800 Classification: Class II Predicate Device(s): K112311 – Currie Medical Specialties, ALP 501RB System K133274 – Innovamed Health LLC, Vena Pro…
Currie Medical Specialties, Inc.2011—
*K133274Vena Pro
Summary page 4
…Class II Predicate Device(s): K112311 – Currie Medical Specialties, ALP 501RB System K133274 – Innovamed Health LLC, Vena Pro K061125 – Doctors Order, DVTcare CA5 Device Description…
Innovamed Health, LLC2014—
*K061125Dvtcare CA5
Summary page 4
…1 – Currie Medical Specialties, ALP 501RB System K133274 – Innovamed Health LLC, Vena Pro K061125 – Doctors Order, DVTcare CA5 Device Description: Currie Medical Specialties (CMS) ALP® VasQcare™ System provides intermittent p…
Doctors Orders2006—

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 23 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 2 of the 17 ancestors have a recall of any class.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects: 1. Increases blood flow velocity 2. Reduces the risk of deep vein thrombosis 3. Enhances blood circulation 4. Reduces pain and swelling 5. Reduces wound healing time 6. Aids in the treatment and healing of stasis dermatitis, venous stasis…

Read the full statement (203 words)

The Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects:

1. Increases blood flow velocity

2. Reduces the risk of deep vein thrombosis

3. Enhances blood circulation

4. Reduces pain and swelling

5. Reduces wound healing time

6. Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs

The ALP® VasQcare™ System consists of a pump and a pair of single use calf sleeves. The pump provides intermittent cycles of compressed air, which alternately inflate the calf sleeves. The compression, when applied properly to the patient, increases blood velocity back to the heart and helps to prevent deep vein thrombosis.

The pump operates on timed cycles consisting of approximately 12 seconds of inflation where the calf sleeve compresses the limb followed by approximately 48 seconds of deflation where there is no pressure applied to the limb. Each limb compresses once per minute.

The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K151158: ALP VasQcare Take Home System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151158

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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