510(k) · Cleared

Recalled · 2011

Thermosuit System

K061023510(k) TraditionalCleared Sep 20, 2006160-day reviewClass II21 CFR 870.5900Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Recovery Systems Hd, LLC · NZE Hyperthermia Monitor

Cleared on Sep 20, 2006 as substantially equivalent to K912051 (Gaymar Industries, Inc., 1991) after a 160-day review. Its family tree reaches back 1 generation to 1991. 18 later devices descend from it. It has been recalled once.

Decided: Sep 20, 2006
Review: 160 days
Class: Class II
Product code: NZE
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K912051 (1991). 18 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
This deviceK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006
Descendant · cites it directly · 11 of its ownK070112 Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007
Descendant · 2 generations on · 9 of its ownK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
Descendant · cites it directly · 6 of its ownK100071 EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010
Descendant · 3 generations on · 4 of its ownK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
Descendant · 3 generations on · 3 of its ownK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2007high 5 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 18 · See all

K070112Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007 · cites it directly11descendants
K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011 · 2 generations on9descendants
K100071EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010 · cites it directly6descendants
K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc. · 2014 · 3 generations on4descendants
K152266Altrix Precision Temperature Management SystemStryker Medical · 2016 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912051	Medi-Therm (Mta-5900) & Detachable Hoses	Gaymar Industries, Inc.	1991	2
0 (this device)	K061023	Thermosuit System	Life Recovery Systems Hd, LLC	2006	—
+1	K070112	Rapidcool Patient Temperature Management System	Medcool, Inc.	2007	—
+2	K100585	Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900	Gaymar Industries, Inc.	2011	—
+1	K100071	Emcoolspad	Emcools Emergency Medical Cooling Systems AG	2010	—
+3	K142702	Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS…	Medivance, Inc.	2014	6
+3	K152266	Altrix Precision Temperature Management System	Stryker Medical	2016	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0
2011	1	0
2012	2	0
2014	1	0
2016	2	0
2017	2	0
2018	1	0
2020	1	0
2023	1	0
2025	5	0

FIG. 1 — Lineage of K061023, 1991–2025Source: 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 NZE? 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 NZE device

#1 K250979 Thermogard HQ™ Temperature Management System…score 11.4 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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
*	K912051	Medi-Therm (Mta-5900) & Detachable Hoses Summary page 1 …odification of a previous version, MTA5900 Medi-Therm IIHyper/Hypothermia System, K912051. Life Recovery Systems 510(k) for ThermoSuit System…	Gaymar Industries, Inc.	1991	2

Also cleared against K912051: 4 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K070112	Rapidcool Patient Temperature Management System	Medcool, Inc.	2007	11
K100071	Emcoolspad	Emcools Emergency Medical Cooling Systems AG	2010	6

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 21, 2011	Not classified	Z-0456-2012	Process control	ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K070112 (Medcool, Inc., 2007) has gone furthest, with 11 descendants of its own.
4 other devices also cite its predicate K912051.

How does its category compare?

All NZE devices

NZE Hyperthermia Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NZE

2in 2025

2007high 2 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZE

Too few NZE 510(k)s in any year since 2007 to give a median.

Recalls per year · NZE

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NZE

2in 2024

2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code NZE, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	1	1
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	1	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	0	0
2024	0	—	0	2
2025	2	—	0	0
2026	0	—	0	—

What is it indicated for?

The ThermoSuit System TM is a thermal regulating system.

Indications for Use are

a. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients;

b. Monitoring of patient temperature.

The ThermoSuit System TM (Size M)is indicated for patients

* greater than 58" (147 cm) and less than 75" (190 cm) in height

* and less than 26" (66 cm) in width.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061023 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061023: Thermosuit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061023

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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