510(k) · Cleared

Cleared

Venodyne DVT Advantage Plus

K011318510(k) TraditionalCleared Oct 25, 2001177-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

Microtek Medical, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Oct 25, 2001 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it.

Decided: Oct 25, 2001
Review: 177 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

60 later devices descend from it, 8 citing it directly.

This deviceK011318 Venodyne DVT Advantage PlusMicrotek Medical, Inc. · 2001
Descendant · cites it directly · 52 of its ownK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
Descendant · cites it directly · 30 of its ownK061125 Dvtcare CA5Doctors Orders · 2006
Descendant · cites it directly · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
Descendant · cites it directly · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
Descendant · 2 generations on · 21 of its ownK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2006high 7 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 60 · See all

K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006 · cites it directly52descendants
K061125Dvtcare CA5Doctors Orders · 2006 · cites it directly30descendants
K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · cites it directly25descendants
K133274Vena ProInnovamed Health, LLC · 2014 · cites it directly22descendants
K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017 · 2 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011318	Venodyne DVT Advantage Plus	Microtek Medical, Inc.	2001	—
+1	K061866	Nanotherm, Vascutherm and Prothermo Therapy Wraps	Thermotek, Inc.	2006	—
+1	K061125	Dvtcare CA5	Doctors Orders	2006	—
+1	K103187	Tripleplay-VT Vascular Therapy System	Wildcat Medical, Inc.	2011	—
+1	K133274	Vena Pro	Innovamed Health, LLC	2014	—
+2	K171685	Med4 Elite	Cool Systems, Inc. (Dba Game Ready)	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2009	1	0
2010	4	0
2011	4	0
2012	1	0
2013	2	0
2014	2	0
2015	3	0
2016	2	0
2017	2	0
2018	3	0
2019	5	0
2020	4	0
2021	7	0
2022	1	0
2023	4	0
2024	6	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K011318, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#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? (60)

See all 60

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

Number	Device	Applicant	Decided	Descendants
K061866	Nanotherm, Vascutherm and Prothermo Therapy Wraps	Thermotek, Inc.	2006	52
K061125	Dvtcare CA5	Doctors Orders	2006	30
K103187	Tripleplay-VT Vascular Therapy System	Wildcat Medical, Inc.	2011	25
K133274	Vena Pro	Innovamed Health, LLC	2014	22
K090074	Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs	Hygia Health Services, Inc.	2009	1
K110358	Venodyne V810	Microtek Medical, Inc.	2011	0
K101702	Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs	Midwest Reprocessing Center, LLC	2010	0
K101330	Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…	Midwest Reprocessing Center, LLC	2010	0

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

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

https://510kreport.com/device/K011318 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011318: Venodyne DVT Advantage Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011318

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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