510(k) · Cleared
ClearedIOB Warming Blankets
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 Dec 27, 2022 as substantially equivalent to K162679 (Iob Medical, Inc., 2017) after a 201-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Dec 27, 2022
- Review
- 201 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021473 (2002). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK021473 Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
- 1 generation backK162679 IOB Temperature Management SystemIob Medical, Inc. · 2017
- This deviceK221669 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 ownK252861 Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232638 FilteredFlo Warming BlanketsIob Medical, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021473 | Bair Hugger Temperature Management System | Augustine Medical, Inc. | 2002 | — |
| −1 | K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017 | — |
| 0 (this device) | K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022 | — |
| +1 | K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023 | — |
| +2 | K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
| +2 | K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K162679 | IOB Temperature Management SystemSummary page 4…CFR # Product Name Code DWJ 870.5900 Thermal Regulating System 6. Predicate Devices: K162679 IOB Temperature Management System 7. Indications for Use The IOB Warming Blankets are indicated for hypothermic patients o… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231596 | IOB Temperature Management System | 2023 | 2 |
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 2 companies; a new generation was cleared every 14.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231596 (Iob Medical, Inc., 2023) has gone furthest, with 2 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. 2022, 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 Warming Blankets are 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/K221669 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221669: IOB Warming Blankets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221669
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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