510(k) · Cleared

Recalled · Class II · 2021

Criticool

K083662510(k) TraditionalCleared Mar 26, 2009106-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

Mtre Advanced Technology, Ltd. · DWJ System, Thermal Regulating

Cleared on Mar 26, 2009 as substantially equivalent to K071341 (Medivance, Inc., 2007) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 2000. 16 later devices descend from it. It has been recalled once.

Decided: Mar 26, 2009
Review: 106 days
Class: Class II
Product code: DWJ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K003349 (2000). 6 ancestors in all, the oldest K811742 (1981). 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
1 generation backK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · Recalled
This deviceK083662 CriticoolMtre Advanced Technology, Ltd. · 2009
Descendant · cites it directly · 9 of its ownK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
Descendant · cites it directly · 4 of its ownK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010 · Recalled
Descendant · 2 generations on · 3 of its ownK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016 · Recalled
Descendant · 3 generations on · 3 of its ownK161602 Arctic Sun Temperature Management SystemMedivance, Inc. · 2016 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2010high 3 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 16 · See all

K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011 · cites it directly9descendants
K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc. · 2014 · 2 generations on4descendants
K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. · 2010 · cites it directly4descendants
K152266Altrix Precision Temperature Management SystemStryker Medical · 2016 · 2 generations on3descendants
K161602Arctic Sun Temperature Management SystemMedivance, Inc. · 2016 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003349	Allon 2001 Modified	Mtre Advanced Technology, Ltd.	2000	—
−1	K024128	Allon 2001 Version 5	Mtre Advanced Technology, Ltd.	2003	1
0 (this device)	K083662	Criticool	Mtre Advanced Technology, Ltd.	2009	—
+1	K100585	Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900	Gaymar Industries, Inc.	2011	—
+2	K142702	Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS…	Medivance, Inc.	2014	6
+1	K101589	Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems	Cincinnati Sub-Zero Products, Inc.	2010	6
+2	K152266	Altrix Precision Temperature Management System	Stryker Medical	2016	1
+3	K161602	Arctic Sun Temperature Management System	Medivance, Inc.	2016	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1991	1	0
2001	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	2	0
2012	3	0
2014	2	0
2016	2	0
2017	1	0
2018	1	0
2020	1	0
2025	3	0

FIG. 1 — Lineage of K083662, 2000–2025Source: 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 DWJ? 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 DWJ device

#1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 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? (2)

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
*	K071341	Modification to Arctic Sun Temperature Management System, Model 2000 Summary page 1 …Reviewing Panel Cardiovascular 10. 5 10 (k) marketing clearance of Medivance ArcticSun system K071341 August 3, 2007 5 10(k) Marketing clearance for AllIon system K024128 - February 10, 2003…	Medivance, Inc.	2007	1
*	K024128	Allon 2001 Version 5 Summary page 1 …) marketing clearance of Medivance ArcticSun system K071341 August 3, 2007 5 10(k) Marketing clearance for AllIon system K024128 - February 10, 2003 K003349 -November 13, 2000…	Mtre Advanced Technology, Ltd.	2003	1

Also cleared against K071341: 3 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K100585	Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900	Gaymar Industries, Inc.	2011	9
K101589	Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems	Cincinnati Sub-Zero Products, Inc.	2010	4
K140078	Tecotherm Neo (T Neo)	Inspiration Healthcare, Ltd.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 20, 2021	Class II	Z-0153-2023	Component design/selection	Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
5 of the 6 ancestors have a recall of any class.
Of its descendants, K100585 (Gaymar Industries, Inc., 2011) has gone furthest, with 9 descendants of its own.
3 other devices also cite its predicate K071341.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DWJ

3in 2025

2007high 8 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWJ

131in 2025

2007high 180 (2011) · low 30 (2020)2026

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

Recalls per year · DWJ

3in 2024

2007high 7 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DWJ

2,384in 2025

2007high 3,455 (2023) · low 40 (2008)2025

MAUDE reports naming product code DWJ, 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	4	106	0	52
2008	3	73	0	40
2009	3	106	6	71
2010	8	134	2	104
2011	4	180	7	136
2012	5	69	1	106
2013	5	77	2	73
2014	4	131	0	116
2015	0	—	1	245
2016	2	—	0	1,400
2017	5	153	3	1,473
2018	3	95	5	1,517
2019	2	—	3	2,294
2020	5	30	2	2,546
2021	2	—	1	2,689
2022	2	—	5	3,226
2023	6	42	0	3,455
2024	2	—	3	3,329
2025	3	131	0	2,384
2026	5	99	3	—

What is it indicated for?

The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083662: Criticool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083662

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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