510(k) Report

510(k) · Cleared

Cleared

Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017

K023800510(k) TraditionalCleared Feb 10, 200388-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

Aircast, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Feb 10, 2003 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 54 later devices descend from it.

Decided
Feb 10, 2003
Review
88 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 2 descendants cleared2006: 2 descendants cleared2013: 2 descendants cleared2019: 5 descendants cleared2011: 2 descendants cleared2017: 2 descendants cleared2024: 6 descendants cleared2018: 3 descendants cleared2014: 2 descendants cleared2026: 4 descendants cleared2025: 3 descendants cleared2021: 7 descendants cleared2023: 4 descendants cleared2020: 4 descendants cleared2015: 3 descendants cleared2016: 2 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK023800 Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf…Aircast, Inc. · 2003
  2. Descendant · cites it directly · 52 of its ownK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
  3. Descendant · 2 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
  4. Descendant · 3 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
  5. Descendant · 2 generations on · 21 of its ownK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
  6. Descendant · 2 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2006: 22010: 22011: 22013: 22014: 22015: 32016: 22017: 22018: 32019: 52020: 42021: 72022: 12023: 42024: 62025: 32026: 4
2006high 7 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 54 · See all
  • K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006 · cites it directly52descendants
  • K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 2 generations on25descendants
  • K133274Vena ProInnovamed Health, LLC · 2014 · 3 generations on22descendants
  • K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017 · 2 generations on21descendants
  • K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 2 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023800Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover…Aircast, Inc.2003—
+1K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.2006—
+2K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.2011—
+3K133274Vena ProInnovamed Health, LLC2014—
+2K171685Med4 EliteCool Systems, Inc. (Dba Game Ready)2017—
+2K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201020
201120
201320
201420
201530
201620
201720
201830
201950
202040
202170
202210
202340
202460
202530
202640
FIG. 1 — Lineage of K023800, 2003–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (54)

See all 54

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

NumberDeviceApplicantDecidedDescendants
K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.200652
K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC20100
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, K061866 (Thermotek, Inc., 2006) has gone furthest, with 52 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?

Prophylaxis for DVT (Deep Vein Thrombosis)

Indications for use as stated in the FDA 510(k) statement.

More from Aircast, Inc.

11 FDA decisions under this applicant name. See the company

  • K024019Arterialflow System, Model 32AAircast, Inc. · 2003
  • K992454Venaflow System, Model 30AAircast, Inc. · 2000
  • K964238Aircast Vena Flow Sterile Disposable CuffsAircast, Inc. · 19971 recall
  • K961676Aircast Venaflow System (Modification)Aircast, Inc. · 1997
  • K933977Aircast Edemaflow SystemAircast, Inc. · 1993

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/K023800 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023800: Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023800

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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