510(k) · Cleared
ClearedHot Pink Pad Warming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xodus Medical, Inc. · DWJ System, Thermal Regulating
Cleared on Apr 16, 2026 as substantially equivalent to K202197 (Stihler Electronic GmbH, 2020) after a 29-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 16, 2026
- Review
- 29 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 deviceK260903 Hot Pink Pad Warming SystemXodus Medical, Inc. · 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) | K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | 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 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 |
|---|---|---|---|
| * | K202197 | Astopad Patient Warming SystemSummary page 5…ch Xodus Medical claims Substantial Equivalence 2.1. Device Name: ASTOPAD Patient Warming System 2.2. Common Name: Thermal Regulating System 2.3. 510(k) Number: K202197 2.4. 510(k) Owner: Stihler Electronic GmbH Julius-Hoelder-Strasse 36 Stuttgart… | 2020 |
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 5 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 Hot Pink Pad Warming System is a non-sterile, electrically conductive patient warming system with adjustable temperature in a predefined range.
The Hot Pink Pad Warming System is to be used during surgical procedures to assist in patient temperature management and prevent inadvertent hypothermia.
The Hot Pink Pad Warming System is intended for use in hospitals and surgery centers.
The Hot Pink Pad Warming System's patient population includes adult and pediatric patients, but excludes neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260903: Hot Pink Pad Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260903
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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