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 Jun 30, 2023 as substantially equivalent to K162679 (Iob Medical, Inc., 2017) and 2 other predicates after a 29-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it.
- Decided
- Jun 30, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K021473 (2002). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK021473 Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
- 2 generations backK162679 IOB Temperature Management SystemIob Medical, Inc. · 2017
- 1 generation backK190221 IOB Warming BlanketsIob Medical, Inc. · 2019
- This deviceK231596 IOB Temperature Management SystemIob Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252861 Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK232638 FilteredFlo Warming BlanketsIob Medical, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −3 | K021473 | Bair Hugger Temperature Management System | Augustine Medical, Inc. | 2002 | — |
| −2 | K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017 | — |
| −1 | K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019 | — |
| 0 (this device) | K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023 | — |
| +1 | K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
| +1 | K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K162679 | IOB Temperature Management SystemSummary page 4…Usual Name: Temperature Management System Classification Name: Thermal Regulating System (21 CFR 870.5900) Regulatory Class: II Product Code: DWJ III. PREDICATE DEVICE K162679 IOB Temperature Management System K190221 IOB Warming Blankets K221669 IOB Warming Blankets IV. DEVICE DESCRIPTION The IOB Temp… | 2017 |
| * | K190221 | IOB Warming BlanketsSummary page 4…Classification Name: Thermal Regulating System (21 CFR 870.5900) Regulatory Class: II Product Code: DWJ III. PREDICATE DEVICE K162679 IOB Temperature Management System K190221 IOB Warming Blankets K221669 IOB Warming Blankets IV. DEVICE DESCRIPTION The IOB Temperature Management System Model IOB-507 co… | 2019 |
| * | K221669 | IOB Warming BlanketsSummary page 4…Regulating System (21 CFR 870.5900) Regulatory Class: II Product Code: DWJ III. PREDICATE DEVICE K162679 IOB Temperature Management System K190221 IOB Warming Blankets K221669 IOB Warming Blankets IV. DEVICE DESCRIPTION The IOB Temperature Management System Model IOB-507 consists of the IOB Warming Uni… | 2022 |
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 21 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252861 (Hangzhou Tappa Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K162679.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Model IOB-507 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/K231596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231596: 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/K231596
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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