510(k) · Cleared
ClearedChillbuster Portable Electric Blanket System, Model 8001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermogear, Inc. · DWJ System, Thermal Regulating
Cleared on Mar 1, 2000 after a 289-day review. The FDA summary names its predicate without a number. 41 later devices descend from it.
- Decided
- Mar 1, 2000
- Review
- 289 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 4 citing it directly.
- This deviceK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- Descendant · cites it directly · 36 of its ownK022903 ChillbusterMicrotek Medical, Inc. · 2002
- Descendant · 2 generations on · 35 of its ownK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- Descendant · 3 generations on · 20 of its ownK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
- Descendant · 4 generations on · 19 of its ownK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
- Descendant · 5 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K022903ChillbusterMicrotek Medical, Inc. · 2002 · cites it directly36descendants
- K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006 · 2 generations on35descendants
- K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010 · 3 generations on20descendants
- K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013 · 4 generations on19descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| +1 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| +2 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| +3 | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | Geratherm Medical AG | 2010 | — |
| +4 | K123002 | Vital Sync System | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013 | — |
| +5 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | Life-Air 1000® Hypothermic Therapy System Named without a submission number |
What descends from it? (41)
See all 414 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022903 (Microtek Medical, Inc., 2002) has gone furthest, with 36 descendants 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.
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 ChillBuster® Model 8001 Portable Electric Blanket System has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.
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/K991684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991684: Chillbuster Portable Electric Blanket System, Model 8001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991684
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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