510(k) · Cleared
ClearedChillbuster Portable Electric Blanket, Model 8002
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 Nov 9, 2007 as substantially equivalent to K991684 (Thermogear, Inc., 2000) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Nov 9, 2007
- Review
- 120 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952329 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952329 Life-Air 1000 Hypothermic Therapy SystemProgressive Dynamics, Inc. · 1996
- This deviceK071918 Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK083135 Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K083135Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952329 | Life-Air 1000 Hypothermic Therapy System | Progressive Dynamics, Inc. | 1996 | — |
| 0 (this device) | K071918 | Chillbuster Portable Electric Blanket, Model 8002 | Thermogear, Inc. | 2007 | — |
| +1 | K083135 | Modification to Chillbuster Portable Electric Blanket , Model 8002 | Thermogear, Inc. | 2008 | — |
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 |
|---|---|---|
| 2008 | 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? (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…alty: Cardiovascular Product Code: DWJ Device Class: 2 Regulation No.: 870.5900 Predicate Devices #K991684 ChillBuster® Model 8001 Portable Electric Blanket, CDRH formal identity: Device Group: System, Thermal Regu… | 2000 |
| * | K952329 | Life-Air 1000 Hypothermic Therapy SystemSummary page 2…Specialty: Cardiovascular Product Code: DWJ Device Class: 2 Regulation No.: 870.5900 #K952329 Life-Air 1000® Hypothermic Therapy System. Its CDRH formal identity is: Device Group: System, Thermal Regulatin… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083135 | Modification to Chillbuster Portable Electric Blanket , Model 8002 | 2008 | 0 |
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. 2007, 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?
The ChillBuster® Model 8002 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. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071918 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071918: Chillbuster Portable Electric Blanket, Model 8002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071918
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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