510(k) · Cleared
ClearedWarming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Tappa Medical Technology Co., Ltd. · DWJ System, Thermal Regulating
Cleared on Apr 7, 2026 as substantially equivalent to K231596 (Iob Medical, Inc., 2023) after a 210-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Apr 7, 2026
- Review
- 210 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021473 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK021473 Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
- 3 generations backK162679 IOB Temperature Management SystemIob Medical, Inc. · 2017
- 2 generations backK190221 IOB Warming BlanketsIob Medical, Inc. · 2019
- 1 generation backK231596 IOB Temperature Management SystemIob Medical, Inc. · 2023
- This deviceK252861 Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021473 | Bair Hugger Temperature Management System | Augustine Medical, Inc. | 2002 | — |
| −3 | K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017 | — |
| −2 | K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019 | — |
| −1 | K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023 | — |
| 0 (this device) | K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K231596 | IOB Temperature Management SystemSummary page 5…CFR 870.5900 Regulatory Class: Class II Product code: DWJ Review Panel: Cardiovascular III. Predicate Devices 510(k) Number: K231596 Trade name: IOB Temperature Management System Common name: System, thermal regulating Classification:… | 2023 |
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 24 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K231596.
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 Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252861: 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/K252861
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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