510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Modification to Arctic Sun Temperature Management System, Model 2000

K071341510(k) SpecialCleared Aug 3, 200781-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

Medivance, Inc. · DWJ System, Thermal Regulating

Cleared on Aug 3, 2007 as substantially equivalent to K010338 (Medivance, Inc., 2001) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1981. 20 later devices descend from it. It has been recalled once.

Decided
Aug 3, 2007
Review
81 days
Class
Class II
Product code
DWJ
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K811742 (1981). 3 ancestors in all. 20 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1991: 1 other ancestor2011: 2 descendants cleared2014: 2 descendants cleared2010: 2 descendants cleared2009: 1 descendant cleared2016: 2 descendants cleared2018: 2 descendants cleared2012: 3 descendants cleared2017: 1 descendant cleared2025: 3 descendants cleared2020: 1 descendant cleared2023: 1 descendant clearedK811742 · Hemotherm Model 400 · Cincinnati Sub-Zero · 1981 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 9 descendants4 generations forward: 1 descendant K811742 · Hemotherm Model 400 · Cincinnati Sub-Zero · 1981 · recalled0
  1. Root · 1 generation backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
  2. This deviceK071341 Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 2007
  3. Descendant · cites it directly · 16 of its ownK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
  4. Descendant · cites it directly · 9 of its ownK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
  5. Descendant · cites it directly · 8 of its ownK101092 Arctic Sun Temperature Management System, Model 5000Medivance, Inc. · 2010 · Recalled
  6. Descendant · 2 generations on · 4 of its ownK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
  7. Descendant · 2 generations on · 4 of its ownK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 22012: 32014: 22016: 22017: 12018: 22020: 12023: 12025: 3
2009high 3 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 20 · See all
  • K083662CriticoolMtre Advanced Technology, Ltd. · 2009 · cites it directly16descendants
  • K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011 · cites it directly9descendants
  • K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc. · 2010 · cites it directly8descendants
  • 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 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K811742Hemotherm Model 400Cincinnati Sub-Zero19812
0 (this device)K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc.2007—
+1K083662CriticoolMtre Advanced Technology, Ltd.20091
+1K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.2011—
+1K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc.20103
+2K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS…Medivance, Inc.20146
+2K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.20106

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201120
201230
201420
201620
201710
201820
202010
202310
202530
FIG. 1 — Lineage of K071341, 1981–2025Source: 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? (3)

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
*K010338Artic Sun Temperature Management System, Model 200
Summary page 1
…nt System, Model 200, is substantially equivalent to the following predicate devices: Arctic Sun Temperature Management System Medivance, Inc. K010338 - Model 2000 MediTherm IISeries 5900 Hyper/Hypothermia System Gaymar Industries K912051 Blanketrol IIHyper/Hy…
Medivance, Inc.20011
*K912051Medi-Therm (Mta-5900) & Detachable Hoses
Summary page 1
…ature Management System Medivance, Inc. K010338 - Model 2000 MediTherm IISeries 5900 Hyper/Hypothermia System Gaymar Industries K912051 Blanketrol IIHyper/Hypothermia System Cincinnati Sub Zero K811742 Intended use of the device The Arctic…
Gaymar Industries, Inc.19912
*K811742Hemotherm Model 400
Summary page 1
…diTherm IISeries 5900 Hyper/Hypothermia System Gaymar Industries K912051 Blanketrol IIHyper/Hypothermia System Cincinnati Sub Zero K811742 Intended use of the device The Arctic Sun Temperature Management System Model 2000 is a thermal regulating system, indicated for…
Cincinnati Sub-Zero19812

Also cleared against K010338: 4 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K083662CriticoolMtre Advanced Technology, Ltd.200916
K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119
K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc.20108
K140078Tecotherm Neo (T Neo)Inspiration Healthcare, Ltd.20140

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 10, 2015Class IIZ-0760-2016Use errorImproper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K083662 (Mtre Advanced Technology, Ltd., 2009) has gone furthest, with 16 descendants of its own.
  • 4 other devices also cite its predicate K010338.

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 Arctic SunTM Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Indications for use as stated in the FDA summary.

Also cleared against K010338

4 other devices cite the same predicate.

  • K120849Hybrid Arcticgel PadMedivance, Inc. · 2012
  • K100071EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010
  • K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc. · 20103 recalls
  • K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002

More from Medivance, Inc.

12 FDA decisions under this applicant name. See the company

  • K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc. · 2025
  • K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2025
  • K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 20201 recall
  • K161602Arctic Sun Temperature Management SystemMedivance, Inc. · 20162 recalls
  • K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal…Medivance, Inc. · 20146 recalls

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/K071341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071341: Modification to Arctic Sun Temperature Management System, Model 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071341

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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