510(k) Report

510(k) · Cleared

Cleared

Rapidcool Patient Temperature Management System

K070112510(k) TraditionalCleared Jul 13, 2007183-day reviewClass II21 CFR 870.5900

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

Medcool, Inc. · DWJ System, Thermal Regulating

Cleared on Jul 13, 2007 as substantially equivalent to K061023 (Life Recovery Systems Hd, LLC, 2006) and 1 other predicate after a 183-day review. Its family tree reaches back 2 generations to 1991. 11 later devices descend from it.

Decided
Jul 13, 2007
Review
183 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K912051 (1991). 3 ancestors in all, the oldest K811742 (1981). 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1981: 1 other ancestor2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2025: 3 descendants cleared2018: 1 descendant cleared2020: 1 descendant clearedK912051 · Medi-Therm (Mta-5900) & Detachable Hoses · Gaymar Industries, Inc. · 1991 · recalledK061023 · Thermosuit System · Life Recovery Systems Hd, LLC · 2006 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K061023 · Thermosuit System · Life Recovery Systems Hd, LLC · 2006 · recalledK912051 · Medi-Therm (Mta-5900) & Detachable Hoses · Gaymar Industries, Inc. · 1991 · recalled0+5
  1. Root · 2 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
  2. 1 generation backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
  3. This deviceK070112 Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007
  4. Descendant · cites it directly · 9 of its ownK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
  5. Descendant · 2 generations on · 4 of its ownK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
  6. Descendant · 2 generations on · 3 of its ownK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016 · Recalled
  7. Descendant · 3 generations on · 3 of its ownK161602 Arctic Sun Temperature Management SystemMedivance, Inc. · 2016 · Recalled
  8. Descendant · 4 generations on · 1 of its ownK200225 Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2020 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12016: 22017: 12018: 12020: 12025: 3
2011high 3 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · 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
  • K152266Altrix Precision Temperature Management SystemStryker Medical · 2016 · 2 generations on3descendants
  • K161602Arctic Sun Temperature Management SystemMedivance, Inc. · 2016 · 3 generations on3descendants
  • K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2020 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K912051Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc.19912
−1K061023Thermosuit SystemLife Recovery Systems Hd, LLC20061
0 (this device)K070112Rapidcool Patient Temperature Management SystemMedcool, Inc.2007—
+1K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.2011—
+2K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS…Medivance, Inc.20146
+2K152266Altrix Precision Temperature Management SystemStryker Medical20161
+3K161602Arctic Sun Temperature Management SystemMedivance, Inc.20162
+4K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.20201

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
201620
201710
201810
202010
202530
FIG. 1 — Lineage of K070112, 1991–2025Source: 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 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. #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K061023Thermosuit System
Summary page 1
…vices The RapidCool Patient Temperature Management System is substantially equivalent to a combination of the Life Recovery Systems ThermoSuit System (K061023) and the Cincinnati Sub Zero Blanketrol (K811742). 4. Device Description The RapidCoolTM Patient Temperature Managemen…
Life Recovery Systems Hd, LLC20061
*K811742Hemotherm Model 400
Summary page 1
…nagement System is substantially equivalent to a combination of the Life Recovery Systems ThermoSuit System (K061023) and the Cincinnati Sub Zero Blanketrol (K811742). 4. Device Description The RapidCoolTM Patient Temperature Management System reduces, and/or maintains patient…
Cincinnati Sub-Zero19812

Also cleared against K061023: 1 other device →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119
K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120

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 16 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K100585 (Gaymar Industries, Inc., 2011) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K061023.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DWJ

3in 2025

2007: 42008: 32009: 32010: 82011: 42012: 52013: 52014: 42016: 22017: 52018: 32019: 22020: 52021: 22022: 22023: 62024: 22025: 32026 (partial year): 5
2007high 8 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWJ

131in 2025

2007: 106 days median2008: 73 days median2009: 106 days median2010: 134 days median2011: 180 days median2012: 69 days median2013: 77 days median2014: 131 days median2017: 153 days median2018: 95 days median2020: 30 days median2023: 42 days median2025: 131 days median2026 (partial year): 99 days median
2007high 180 (2011) · low 30 (2020)2026

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

Recalls per year · DWJ

3in 2024

2009: 62010: 22011: 72012: 12013: 22015: 12017: 32018: 52019: 32020: 22021: 12022: 52024: 32026 (partial year): 3
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

2007: 522008: 402009: 712010: 1042011: 1362012: 1062013: 732014: 1162015: 2452016: 1,4002017: 1,4732018: 1,5172019: 2,2942020: 2,5462021: 2,6892022: 3,2262023: 3,4552024: 3,3292025: 2,384
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074106052
2008373040
20093106671
201081342104
201141807136
20125691106
2013577273
201441310116
20150—1245
20162—01,400
2017515331,473
201839551,517
20192—32,294
202053022,546
20212—12,689
20222—53,226
202364203,455
20242—33,329
2025313102,384
20265993—

What is it indicated for?

The RapidCool Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.

Indications for use as stated in the FDA summary.

Also cleared against K061023

1 other device cites the same predicate.

  • K100071EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010

Recent decisions in DWJ

The DWJ category page

  • K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026
  • K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
  • K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
  • K260903Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
  • K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K070112 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070112: Rapidcool Patient Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070112

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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