510(k) · Cleared
ClearedUnique Temp Warming Blankets, Model 8001140XXX
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 Oct 19, 2010 as substantially equivalent to K052392 (Augustine Biomedical & Design, LLC, 2006) after a 369-day review. Its family tree reaches back 3 generations to 2000. 20 later devices descend from it.
- Decided
- Oct 19, 2010
- Review
- 369 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991684 (2000). 4 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- 2 generations backK022903 ChillbusterMicrotek Medical, Inc. · 2002
- 1 generation backK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- This deviceK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
- Descendant · cites it directly · 19 of its ownK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
- Descendant · 2 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 3 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 3 generations on · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 4 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013 · cites it directly19descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 2 generations on18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 3 generations on17descendants
- K152258T3 SoftwareEtiometry, Inc. · 2016 · 3 generations on16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| −2 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| −1 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| 0 (this device) | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | Geratherm Medical AG | 2010 | — |
| +1 | K123002 | Vital Sync System | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013 | — |
| +2 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +3 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
| +3 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +4 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K052392 | Hot Dog Patient Warming SystemSummary page 1…Warming systems / blankets Classification Name: Thermal regulating systems (21 CFR 870.5900, Product code DWJ) Substantial Equivalence Warming System: 5 10(k)-Number: K052392 - Hot Dog Patient Warming System Firm: AUGUST[NE BIOMEDICAL & DESIGN, LLC. Description of the Device: Geratherm UniqueTemp 0 ha… | 2006 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123002 | Vital Sync System | 2013 | 19 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K123002 (Covidien, Formerly Nellcor Puritan Bennett, Inc., 2013) has gone furthest, with 19 descendants of its own.
- 4 other devices also cite its predicate K052392.
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 UniqueTemp0 is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093244: Unique Temp Warming Blankets, Model 8001140XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093244
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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