510(k) · Cleared
Cleared3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
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 Apr 29, 2021 as substantially equivalent to K171373 (3M Company, 2017) after a 59-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Apr 29, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001149 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001149 Augustine Medical Bair Huuger, Model 750 Total Temperature…Augustine Medical, Inc. · 2000 · Recalled
- 1 generation backK171373 3M Bair Hugger Model 675 Total Temperature Management System3M Company · 2017
- This deviceK210605 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management… | Augustine Medical, Inc. | 2000 | 1 |
| −1 | K171373 | 3M Bair Hugger Model 675 Total Temperature Management System | 3M Company | 2017 | — |
| 0 (this device) | K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | 2021 | — |
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 |
|---|---|---|---|
| * | K171373 | 3M Bair Hugger Model 675 Total Temperature Management SystemSummary page 5…al Regulating System [21 CFR § 870.5900, DWJ] Predicate Device 3M TM Bair Hugger TM Model 675 Total Temperature Management System, K171373 Reference Devices Bair Paws® Temperature Management System, K060865 Indications for Use The 3MTM Bair HuggerT M Universal War… | 2017 |
| † | K060865 | Bair Paws Temperature Management System Model 850 | 2006 |
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 21 years and passes through 2 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K171373.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is part of the 3M patient temperature management system ('the system') when used with Bair Hugger 700 series or 675 warming unit. The system, monitored and controlled by a trained clinician, is used perioperatively to prevent and treat hypothermia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210605: 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210605
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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