510(k) · Cleared
ClearedHybrid Arcticgel Pad
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 Jul 20, 2012 as substantially equivalent to K010338 (Medivance, Inc., 2001) and 1 other predicate after a 122-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 20, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912051 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 2 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- 1 generation backK100071 EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010
- This deviceK120849 Hybrid Arcticgel PadMedivance, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −2 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| −1 | K100071 | Emcoolspad | Emcools Emergency Medical Cooling Systems AG | 2010 | — |
| 0 (this device) | K120849 | Hybrid Arcticgel Pad | Medivance, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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 |
|---|---|---|---|
| * | K010338 | Artic Sun Temperature Management System, Model 200Summary page 1…ct Code: DWJ Predicate Devices * Medivance Arctic Sun ArcticGel Pad K01 0338 * EMCOOLS Pad K1 00071… | 2001 |
| * | K100071 | EmcoolspadSummary page 1…nce Arctic Sun ArcticGel Pad K01 0338 * EMCOOLS Pad K1 00071 Device Description The Arctic Sun Hybrid ArcticGel Pads are a modified ver… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K010338.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Hybrid ArcticGel Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia).
Additionally, the Hybrid ArcticGel Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System.
The Hybrid ArcticGel Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in-hospital as well as EMS/transport settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120849: Hybrid Arcticgel Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120849
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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