510(k) Report

510(k) · Cleared

Cleared

Bair Hugger Temperature Management System

K021473510(k) TraditionalCleared Jul 9, 200262-day reviewClass II21 CFR 870.5900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Augustine Medical, Inc. · DWJ System, Thermal Regulating

Cleared on Jul 9, 2002 after a 62-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.

Decided
Jul 9, 2002
Review
62 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants cleared2014: 2 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants cleared2009: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK021473 Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
  2. Descendant · cites it directly · 7 of its ownK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
  3. Descendant · cites it directly · 6 of its ownK162679 IOB Temperature Management SystemIob Medical, Inc. · 2017
  4. Descendant · 2 generations on · 6 of its ownK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK190221 IOB Warming BlanketsIob Medical, Inc. · 2019
  6. Descendant · 3 generations on · 4 of its ownK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22009: 12014: 22017: 12018: 12019: 12022: 12023: 22024: 12026: 2
2004high 2 (2006) · low 0 (2005)2026

Most influential descendants

Showing 5 of 15 · See all
  • K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004 · cites it directly7descendants
  • K162679IOB Temperature Management SystemIob Medical, Inc. · 2017 · cites it directly6descendants
  • K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · 2 generations on6descendants
  • K190221IOB Warming BlanketsIob Medical, Inc. · 2019 · 2 generations on4descendants
  • K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021473Bair Hugger Temperature Management SystemAugustine Medical, Inc.2002—
+1K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc.2004—
+1K162679IOB Temperature Management SystemIob Medical, Inc.2017—
+2K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc.20064
+2K190221IOB Warming BlanketsIob Medical, Inc.2019—
+3K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc.20066

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200910
201420
201710
201810
201910
202210
202320
202410
202620
FIG. 1 — Lineage of K021473, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Augustine Medical, Bair Hugger Model 600 Hyper/hypothermia unit used with Bair Hugger…
Named without a submission number
—
*—Seabrook Medical Systems, Tropi-Cool Hyperhypothermia unit used with Temp-pad blankets
Named without a submission number
—

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc.20047
K162679IOB Temperature Management SystemIob Medical, Inc.20176

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?

  • Of its descendants, K041686 (Arizant Healthcare, Inc., 2004) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWJ

3in 2025

2007: 42008: 32009: 32010: 82011: 42012: 52013: 52014: 42016: 22017: 52018: 32019: 22020: 52021: 22022: 22023: 62024: 22025: 32026 (partial year): 5
2007high 8 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWJ

131in 2025

2007: 106 days median2008: 73 days median2009: 106 days median2010: 134 days median2011: 180 days median2012: 69 days median2013: 77 days median2014: 131 days median2017: 153 days median2018: 95 days median2020: 30 days median2023: 42 days median2025: 131 days median2026 (partial year): 99 days median
2007high 180 (2011) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWJ

3in 2024

2009: 62010: 22011: 72012: 12013: 22015: 12017: 32018: 52019: 32020: 22021: 12022: 52024: 32026 (partial year): 3
2007high 7 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWJ

2,384in 2025

2007: 522008: 402009: 712010: 1042011: 1362012: 1062013: 732014: 1162015: 2452016: 1,4002017: 1,4732018: 1,5172019: 2,2942020: 2,5462021: 2,6892022: 3,2262023: 3,4552024: 3,3292025: 2,384
2007high 3,455 (2023) · low 40 (2008)2025

MAUDE reports naming product code DWJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074106052
2008373040
20093106671
201081342104
201141807136
20125691106
2013577273
201441310116
20150—1245
20162—01,400
2017515331,473
201839551,517
20192—32,294
202053022,546
20212—12,689
20222—53,226
202364203,455
20242—33,329
2025313102,384
20265993—

What is it indicated for?

The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.

Indications for use as stated in the FDA summary.

More from Augustine Medical, Inc.

25 FDA decisions under this applicant name. See the company

  • K020077Modification to Augustine Medical Wound Care System, Model 68XXXAugustine Medical, Inc. · 2002
  • K001149Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair…Augustine Medical, Inc. · 20001 recall
  • K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 19981 Class I recall
  • K964673Bair Hugger Model 630 Cardiac BlanketAugustine Medical, Inc. · 1997
  • K963293Augustine Medical Wound Care System Model 68XXXAugustine Medical, Inc. · 1997

Recent decisions in DWJ

The DWJ category page

  • K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026
  • K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
  • K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
  • K260903Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
  • K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K021473 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021473: Bair Hugger Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021473

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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