510(k) Report

510(k) · Cleared

Recalled · 2005

Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads

K002577510(k) TraditionalCleared Oct 26, 200069-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 Oct 26, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it. It has been recalled once.

Decided
Oct 26, 2000
Review
69 days
Class
Class II
Product code
DWJ
Recalls
1
Predicates
0

26 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2014: 2 descendants cleared2007: 2 descendants cleared2006: 1 descendant cleared2016: 3 descendants cleared2005: 2 descendants cleared2008: 3 descendants cleared2004: 1 descendant cleared2012: 1 descendant cleared2020: 1 descendant cleared2025: 2 descendants cleared2010: 1 descendant cleared2015: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK002577 Arctic Sun Temperature Management System, Model 100 Control Unit and…Medivance, Inc. · 2000
  2. Descendant · cites it directly · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
  3. Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
  4. Descendant · 3 generations on · 8 of its ownK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
  5. Descendant · 4 generations on · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
  6. Descendant · 4 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2003: 32004: 12005: 22006: 12007: 22008: 32010: 12012: 12014: 22015: 12016: 32020: 12021: 12022: 12023: 12025: 2
2003high 3 (2003) · low 0 (2009)2026

Most influential descendants

Showing 5 of 26 · See all
  • K022366Celsius Control SystemInnercool Therapies · 2003 · cites it directly16descendants
  • K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
  • K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005 · 3 generations on8descendants
  • K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · 4 generations on7descendants
  • K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002577Arctic Sun Temperature Management System, Model 100 Control Unit and Patient…Medivance, Inc.2000—
+1K022366Celsius Control SystemInnercool Therapies2003—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.20034
+3K052443Icy Catheter, Model IC-3893AAlsius Corp.2005—
+4K070161Quattro Catheter Model IC4593Alsius Corp.2007—
+4K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro…Zoll Circulation2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200410
200520
200610
200720
200830
201010
201210
201420
201510
201630
202010
202110
202210
202310
202520
FIG. 1 — Lineage of K002577, 2000–2025Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K022366Celsius Control SystemInnercool Therapies200316
K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.20144
K033021Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer PadsKimberly-Clark Corp.20033

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 5, 2005Not classifiedZ-0436-05OtherPotential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022366 (Innercool Therapies, 2003) has gone furthest, with 16 descendants of its own.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

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/K002577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002577: Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002577

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026