510(k) · Cleared
ClearedIOB Temperature Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iob Medical, Inc. · DWJ System, Thermal Regulating
Cleared on Apr 28, 2017 as substantially equivalent to K021473 (Augustine Medical, Inc., 2002) after a 214-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.
- Decided
- Apr 28, 2017
- Review
- 214 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021473 (2002). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK021473 Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
- This deviceK162679 IOB Temperature Management SystemIob Medical, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK190221 IOB Warming BlanketsIob Medical, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK221669 IOB Warming BlanketsIob Medical, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK231596 IOB Temperature Management SystemIob Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK262089 Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252861 Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190221IOB Warming BlanketsIob Medical, Inc. · 2019 · cites it directly4descendants
- K221669IOB Warming BlanketsIob Medical, Inc. · 2022 · cites it directly3descendants
- K231596IOB Temperature Management SystemIob Medical, Inc. · 2023 · cites it directly2descendants
- K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021473 | Bair Hugger Temperature Management System | Augustine Medical, Inc. | 2002 | — |
| 0 (this device) | K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017 | — |
| +1 | K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019 | — |
| +1 | K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022 | — |
| +1 | K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023 | — |
| +2 | K262089 | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
| +2 | K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K021473 | Bair Hugger Temperature Management SystemSummary page 4…CFR # Product Name Code DWJ 870.5900 Thermal Regulating System 6. Predicate Devices: K021473 Bair Hugger Temperature Management System 7. Intended Use The IOB Temperature Management system is indicated for hypotherm… | 2002 |
What descends from it? (6)
3 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?
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 IOB Temperature Management system is indicated for hypothermic patients or normothermic patients for whom
induced hyperthermia or localized increase in temperature is clinically indicated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162679: IOB Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162679
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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