510(k) · Cleared

Cleared

Nanotherm, Vascutherm and Prothermo Therapy Wraps

K061866510(k) TraditionalCleared Aug 22, 200650-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 Aug 22, 2006 as substantially equivalent to K942796 (Chattanooga Group, Inc., 1995) and 5 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1995. 52 later devices descend from it.

Decided: Aug 22, 2006
Review: 50 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K944567 (1995). 7 ancestors in all, the oldest K942796 (1995). 52 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 2 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
1 generation backK981311 Cowboy XVKci New Technologies, Inc. · 1999
This deviceK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
Descendant · cites it directly · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
Descendant · 2 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
Descendant · cites it directly · 21 of its ownK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
Descendant · cites it directly · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
Descendant · cites it directly · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2010high 7 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 52 · See all

K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · cites it directly25descendants
K133274Vena ProInnovamed Health, LLC · 2014 · 2 generations on22descendants
K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017 · cites it directly21descendants
K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · cites it directly12descendants
K190854Therm-XZenith Technical Innovations · 2019 · cites it directly11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944567	Cowboy X	Kinetic Concepts, Inc.	1995	1
−1	K981311	Cowboy XV	Kci New Technologies, Inc.	1999	—
0 (this device)	K061866	Nanotherm, Vascutherm and Prothermo Therapy Wraps	Thermotek, Inc.	2006	—
+1	K103187	Tripleplay-VT Vascular Therapy System	Wildcat Medical, Inc.	2011	—
+2	K133274	Vena Pro	Innovamed Health, LLC	2014	—
+1	K171685	Med4 Elite	Cool Systems, Inc. (Dba Game Ready)	2017	—
+1	K181149	Therm-X Pro, Therm-X AT, Therm-X Pro Athlete	Zenith Technical Innovations	2018	—
+1	K190854	Therm-X	Zenith Technical Innovations	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	1	0
2001	1	0
2003	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	2	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 K061866, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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? (6)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K942796	Presssion S Iii Summary page 1 …(per 21 CFR section 870.5800) IDENTIFICATION OF PREDICATE DEVICES [As Required by 21 CFR 807.92 a(3)] * Chattanooga Group, Inc. PresSsion S 11I K942796 * KCI PlexiPulse® All-in-I System K981311 · Aircast VenaFlow System Disposable Cuffs K023800 as bundled * Bi…	Chattanooga Group, Inc.	1995	—
*	K981311	Cowboy XV Summary page 1 …ICATION OF PREDICATE DEVICES [As Required by 21 CFR 807.92 a(3)] * Chattanooga Group, Inc. PresSsion S 11I K942796 * KCI PlexiPulse® All-in-I System K981311 · Aircast VenaFlow System Disposable Cuffs K023800 as bundled * Bio Compression Systems BioComfort K043423 Ga…	Kci New Technologies, Inc.	1999	—
*	K023800	Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017 Summary page 1 …07.92 a(3)] * Chattanooga Group, Inc. PresSsion S 11I K942796 * KCI PlexiPulse® All-in-I System K981311 · Aircast VenaFlow System Disposable Cuffs K023800 as bundled * Bio Compression Systems BioComfort K043423 Garments * MicroTek Medical Holdings, Inc. K…	Aircast, Inc.	2003	—
*	K043423	Model SC-3008 Sequential Circulator Summary page 1 …* KCI PlexiPulse® All-in-I System K981311 · Aircast VenaFlow System Disposable Cuffs K023800 as bundled * Bio Compression Systems BioComfort K043423 Garments * MicroTek Medical Holdings, Inc. K011318 Venodyne DVT Advantage Plus+ * Ormed Artrotherm Cryot…	Bio Compression Systems, Inc.	2005	—
*	K011318	Venodyne DVT Advantage Plus Summary page 1 …naFlow System Disposable Cuffs K023800 as bundled * Bio Compression Systems BioComfort K043423 Garments * MicroTek Medical Holdings, Inc. K011318 Venodyne DVT Advantage Plus+ * Ormed Artrotherm Cryotherapy and K964799 sited and currently exempt Thernot…	Microtek Medical, Inc.	2001	—
*	K964799	Artrotherm Cryotherapy and Thernotherapy Summary page 1 …t K043423 Garments * MicroTek Medical Holdings, Inc. K011318 Venodyne DVT Advantage Plus+ * Ormed Artrotherm Cryotherapy and K964799 sited and currently exempt Thernothcrapy Class II, per 21 CFR 890.5720…	Ormed GmbH	1997	—

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K103187	Tripleplay-VT Vascular Therapy System	Wildcat Medical, Inc.	2011	25
K171685	Med4 Elite	Cool Systems, Inc. (Dba Game Ready)	2017	21
K181149	Therm-X Pro, Therm-X AT, Therm-X Pro Athlete	Zenith Technical Innovations	2018	12
K190854	Therm-X	Zenith Technical Innovations	2019	11
K240125	Therm-X (Home); Therm-X (AT)	Zenith Technical Innovations	2024	0
K122640	Vpulse	Cothera, LLC	2013	0
K111748	Recovery+ Model PS 511, Dvtherapy Model PS 511A	Joy Long	2011	0
K103247	Vascucomp	Thermotek, Inc.	2010	0
K100969	Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…	Wmi Enterprises, 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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K103187 (Wildcat Medical, Inc., 2011) has gone furthest, with 25 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	—

What is it indicated for?

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. Treatment of disorders associated with…

Read the full statement (157 words)

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.

Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.

Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.

Reduction of edema associated with soft tissue injuries such as bums, postoperative edema, and ligament sprains.

Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

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 would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061866 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061866: Nanotherm, Vascutherm and Prothermo Therapy Wraps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061866

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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