510(k) · Cleared
ClearedChillbuster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtek Medical, Inc. · DWJ System, Thermal Regulating
Cleared on Nov 27, 2002 as substantially equivalent to K991684 (Thermogear, Inc., 2000) after an 85-day review. Its family tree reaches back 1 generation to 2000. 36 later devices descend from it.
- Decided
- Nov 27, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991684 (2000). 36 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- This deviceK022903 ChillbusterMicrotek Medical, Inc. · 2002
- Descendant · cites it directly · 35 of its ownK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- Descendant · 2 generations on · 20 of its ownK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
- Descendant · 3 generations on · 19 of its ownK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
- Descendant · 4 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 5 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006 · cites it directly35descendants
- K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010 · 2 generations on20descendants
- K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013 · 3 generations on19descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 4 generations on18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 5 generations on17descendants
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) | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| +1 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| +2 | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | Geratherm Medical AG | 2010 | — |
| +3 | K123002 | Vital Sync System | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013 | — |
| +4 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +5 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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 |
|---|---|---|---|
| * | K991684 | Chillbuster Portable Electric Blanket System, Model 8001Summary page 1…c.) Classification: I1 (74 DWJ) Statement of Substantial Equivalence ChillBusterTMPortable Electric Blanket is equivalent to: 1. ChillBusterTM(ThermoGear K99 1684) 2. Life-Air 1000 (Progressive Dynamics Inc., Marshall, MI) Description of Device Portable Electri… | 2000 |
| * | — | Life-Air 1000 Named without a submission number |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052392 | Hot Dog Patient Warming System | 2006 | 35 |
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?
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?
ChillBmterTMPortable Electric Blanket is to be used 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 as stated in the FDA summary.
https://510kreport.com/device/K022903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022903: Chillbuster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022903
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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