510(k) · Cleared
Recalled · Class II · 2024Arctic Sun Temperature Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivance, Inc. · DWJ System, Thermal Regulating
Cleared on Sep 2, 2016 as substantially equivalent to K142702 (Medivance, Inc., 2014) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 2, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912051 (1991). 13 ancestors in all, the oldest K811742 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 4 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- 3 generations backK070112 Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007
- 2 generations backK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
- 1 generation backK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
- This deviceK161602 Arctic Sun Temperature Management SystemMedivance, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK200225 Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK251974 Arctic Sun Temperature Management System (Model 5000)Medivance, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243942 Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2020 · cites it directly1descendant
- K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc. · 2025 · cites it directly0descendants
- K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −4 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| −3 | K070112 | Rapidcool Patient Temperature Management System | Medcool, Inc. | 2007 | — |
| −2 | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011 | — |
| −1 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS… | Medivance, Inc. | 2014 | 6 |
| 0 (this device) | K161602 | Arctic Sun Temperature Management System | Medivance, Inc. | 2016 | — |
| +1 | K200225 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2020 | 1 |
| +1 | K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | 2025 | — |
| +2 | K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Summary page 4…II Product Code: DWJ Predicate Device K142702 Arctic Sun® Temperature Management System Medivance, Inc.… | 2014 |
| * | K101092 | Arctic Sun Temperature Management System, Model 5000Summary page 4…Arctic Sun® Temperature Management System Medivance, Inc. K101092 Indications for Use The Arctic Sun Temperature Management System is a thermal regulating system, indicated… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2024 | Class II | Z-2457-2024 | Software design | If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an… |
| Jun 13, 2018 | Class II | Z-2536-2018 | Process control | An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 10 of the 13 ancestors have a recall of any class.
- Of its descendants, K200225 (Medivance, Inc., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 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 Arctic Sun® Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161602 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161602: Arctic Sun 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/K161602
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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