510(k) · Cleared
ClearedModification to Chillbuster 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 Oct 31, 2008 as substantially equivalent to K071918 (Thermogear, Inc., 2007) and 1 other predicate after an 8-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Oct 31, 2008
- Review
- 8 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952329 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK952329 Life-Air 1000 Hypothermic Therapy SystemProgressive Dynamics, Inc. · 1996
- 1 generation backK071918 Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc. · 2007
- This deviceK083135 Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952329 | Life-Air 1000 Hypothermic Therapy System | Progressive Dynamics, Inc. | 1996 | — |
| −1 | K071918 | Chillbuster Portable Electric Blanket, Model 8002 | Thermogear, Inc. | 2007 | — |
| 0 (this device) | 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 |
| 2007 | 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 |
|---|---|---|---|
| * | K071918 | Chillbuster Portable Electric Blanket, Model 8002Summary page 1…lar Product Code: DWJ Device Class: 2 Regulation No: 870.5900 Predicate Devices #K071918 ChillBuster ® Model 8002 Portable Electric Blanket; ThermoGear Inc; #K072513 DM-EMG Hypothermic Therapy System; Medvation L… | 2007 |
| * | K072513 | DM-EMGSummary page 1…2 Regulation No: 870.5900 Predicate Devices #K071918 ChillBuster ® Model 8002 Portable Electric Blanket; ThermoGear Inc; #K072513 DM-EMG Hypothermic Therapy System; Medvation LLC. Device Description This device, as now cleared, permits use with either… | 2007 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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/K083135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083135: Modification to Chillbuster Portable Electric Blanket , Model 8002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083135
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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