510(k) · Cleared
ClearedGeratherm Sos-Rescue Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R.G. Enterprises, Inc. · DWJ System, Thermal Regulating
Cleared on Jun 29, 2006 as substantially equivalent to K991684 (Thermogear, Inc., 2000) after a 402-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 29, 2006
- Review
- 402 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991684 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- This deviceK051336 Geratherm Sos-Rescue BagR.G. Enterprises, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| 0 (this device) | K051336 | Geratherm Sos-Rescue Bag | R.G. Enterprises, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K991684 | Chillbuster Portable Electric Blanket System, Model 8001Summary page 1…Thermal Regulating System (870.5900) Predicate Device - ChillBusterTm Portable Electric Blanket (Thermogear, Inc. K991684) The following material presents the 5 10 (k) Summary… | 2000 |
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.
- 3 other devices also cite its predicate K991684.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Geratherm SOS-Rescue Bag is a temperature controlled electric whole body warming system intended for use in preventing or treating the effects of hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051336: Geratherm Sos-Rescue Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051336
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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