510(k) · Cleared
Cleared3M Bair Hugger Model 675 Total Temperature Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · DWJ System, Thermal Regulating
Cleared on Oct 10, 2017 as substantially equivalent to K001149 (Augustine Medical, Inc., 2000) after a 153-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Oct 10, 2017
- Review
- 153 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001149 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001149 Augustine Medical Bair Huuger, Model 750 Total Temperature…Augustine Medical, Inc. · 2000 · Recalled
- This deviceK171373 3M Bair Hugger Model 675 Total Temperature Management System3M Company · 2017
- Descendant · cites it directly · 1 of its ownK210603 3M Bair Hugger Temperature Management System (Model 675)3M Company · 2021
- Descendant · 2 generations on · 0 of its ownK231211 Medline ComfortTemp Patient Warming SystemMedline Industries, LP · 2023
- Descendant · cites it directly · 0 of its ownK210605 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company · 2021
Most influential descendants
Showing 3 of 3 · See all- K2106033M Bair Hugger Temperature Management System (Model 675)3M Company · 2021 · cites it directly1descendant
- K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LP · 2023 · 2 generations on0descendants
- K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management… | Augustine Medical, Inc. | 2000 | 1 |
| 0 (this device) | K171373 | 3M Bair Hugger Model 675 Total Temperature Management System | 3M Company | 2017 | — |
| +1 | K210603 | 3M Bair Hugger Temperature Management System (Model 675) | 3M Company | 2021 | — |
| +2 | K231211 | Medline ComfortTemp Patient Warming System | Medline Industries, LP | 2023 | — |
| +1 | K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…Summary page 4…use Predicate Device: Augustine Medical Bair Hugger Model 750 Total Temperature Management System, K001149. Relevant chronological information regarding the predicate device K001149 was cleared on September… | 2000 |
| † | K021473 | Bair Hugger Temperature Management System | 2002 |
What descends from it? (3)
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?
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 Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.
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/K171373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171373: 3M Bair Hugger Model 675 Total 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/K171373
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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