510(k) · Cleared
ClearedAstopad Patient Warming 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 Sep 4, 2020 as substantially equivalent to K112488 (Augustine Biomedical & Design, LLC, 2011) after a 30-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Sep 4, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991684 (2000). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- 3 generations backK022903 ChillbusterMicrotek Medical, Inc. · 2002
- 2 generations backK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- 1 generation backK112488 Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC · 2011
- This deviceK202197 Astopad Patient Warming SystemStihler Electronic GmbH · 2020
- Descendant · cites it directly · 0 of its ownK260278 ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
- Descendant · cites it directly · 0 of its ownK260903 Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| −3 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| −2 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| −1 | K112488 | Hotdog Patient Warming System | Augustine Biomedical & Design, LLC | 2011 | — |
| 0 (this device) | K202197 | Astopad Patient Warming System | Stihler Electronic GmbH | 2020 | — |
| +1 | K260278 | ThermAffyx (TM) Patient Safety System | Stihler Electronic GmbH | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K112488 | Hotdog Patient Warming SystemSummary page 4…Class: DWJ) Class II III. PREDICATE DEVICE HotDog Patient Warming System, K112488 This predicate has not been subject to a design-related recall. 1 IV.… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K260278 (Stihler Electronic GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112488.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 ASTOPAD® Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The ASTOPAD Patient Warming System is indicated for use in all areas of healthcare facilities for preventing or treating hypothermia or maintaining normothermia. The warming blankets can be used over or under the patient (pediatric and adult) by appropriately trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202197: Astopad Patient 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/K202197
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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