510(k) · Cleared
ClearedThermAffyx (TM) Patient Safety System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stihler Electronic GmbH · DWJ System, Thermal Regulating
Cleared on Jul 8, 2026 as substantially equivalent to K202197 (Stihler Electronic GmbH, 2020) after a 160-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Jul 8, 2026
- Review
- 160 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K991684 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- 4 generations backK022903 ChillbusterMicrotek Medical, Inc. · 2002
- 3 generations backK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- 2 generations backK112488 Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC · 2011
- 1 generation backK202197 Astopad Patient Warming SystemStihler Electronic GmbH · 2020
- This deviceK260278 ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| −4 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| −3 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| −2 | K112488 | Hotdog Patient Warming System | Augustine Biomedical & Design, LLC | 2011 | — |
| −1 | K202197 | Astopad Patient Warming System | Stihler Electronic GmbH | 2020 | — |
| 0 (this device) | K260278 | ThermAffyx (TM) Patient Safety System | Stihler Electronic GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 K262089 Disposable Warming Blanketscore 12.5 · 3 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 |
|---|---|---|---|
| * | K202197 | Astopad Patient Warming SystemSummary page 5…Trade Name Applicant ASTOPAD® Stihler Electronics GmbH (part of K202197 DWJ Gentherm Medical, LLC)… | 2020 |
| * | — | PrimePad® Named without a submission number |
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 26 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K202197.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ThermAffyx(TM) Patient Safety System is intended to maintain normothermia, treat hypothermia and provide anti-slip positioning securement for patients.
The system is intended to be used by trained healthcare professionals in all areas of professional healthcare facilities.
It is indicated for use on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260278: ThermAffyx (TM) Patient Safety System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260278
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026