510(k) · Cleared
ClearedGeratherm Uniqueresc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geratherm Medical AG · DWJ System, Thermal Regulating
Cleared on Sep 20, 2010 as substantially equivalent to K051097 (Rg Ent., Inc., 2006) after a 294-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Sep 20, 2010
- Review
- 294 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051097 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK051097 Geratherm Sos-Rescue BlanketRg Ent., Inc. · 2006
- This deviceK093694 Geratherm UniquerescGeratherm Medical AG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051097 | Geratherm Sos-Rescue Blanket | Rg Ent., Inc. | 2006 | — |
| 0 (this device) | K093694 | Geratherm Uniqueresc | Geratherm Medical AG | 2010 | — |
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? (1)
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 |
|---|---|---|---|
| * | K051097 | Geratherm Sos-Rescue BlanketSummary page 1…rming systems / blankets Classification Name: Thermal regulating systems (21 CFR 870.5900, Product code DWJ) Substantial Equivalence Warming System: 5 10(k)-Number: KO051097, GERATHERM SOS-RESCUE BLANKET, RG ENT., INC., 28351 Beck Rd., Wixom, MI 48393 Description of the Device: Geratherm UniqueResc'… | 2006 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Geratherm UniqueResc is a thermal regulating system for adult patients in order to prevent hypothermia in preclinical settings or treatments on-site. It is intended for use while at the rescue scene, during patient transport by air or ground to a medical facility or e.g. during disaster operation in first aid tents. The device should be used by appropriately trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093694 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093694: Geratherm Uniqueresc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093694
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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