510(k) Report

510(k) · Cleared

Cleared

Bair Hugger Temperature Management System

K041686510(k) SpecialCleared Jun 30, 20048-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

Arizant Healthcare, Inc. · DWJ System, Thermal Regulating

Cleared on Jun 30, 2004 as substantially equivalent to K021473 (Augustine Medical, Inc., 2002) and 4 other predicates after an 8-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it.

Decided
Jun 30, 2004
Review
8 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K873745 (1987). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1990: 1 other ancestor2006: 2 descendants cleared2014: 2 descendants cleared2009: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant clearedK873745 · Bair Hugger (TM) - Patient Warming System · Augustine Medical, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K873745 · Bair Hugger (TM) - Patient Warming System · Augustine Medical, Inc. · 19870+5
  1. Root · 1 generation backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
  2. This deviceK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
  3. Descendant · cites it directly · 6 of its ownK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
  6. Descendant · 4 generations on · 1 of its ownK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
  7. Descendant · 3 generations on · 0 of its ownK232502 Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 22009: 12014: 22018: 12024: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all
  • K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · cites it directly6descendants
  • K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · 2 generations on4descendants
  • K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc. · 2009 · 3 generations on2descendants
  • K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc. · 2014 · 4 generations on1descendant
  • K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K873745Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc.1987—
0 (this device)K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc.2004—
+1K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc.20064
+2K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc.20066
+3K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model…Smiths Medical Asd, Inc.2009—
+4K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming…Smith Medical Asd, Inc.2014—
+3K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199610
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200910
201420
201810
202410
FIG. 1 — Lineage of K041686, 1987–2024Source: 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? (5)

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
*K021473Bair Hugger Temperature Management System
Summary page 1
…on/usual name: Hyper/Hlypothermiia System Classification name: System, Thermal, Regulating, DWJ Equivalent marketed device: Blair Hugger temperature management system (K02 1473, KOOI1 149, K960 167, K903360, K873745). Device description: The Bair Hugger temperature management system consists of a portabl…
Augustine Medical, Inc.2002—
*K001149Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…Augustine Medical, Inc.20001
*K960167System, Thermal Regulating 74-DWJ
Summary page 1
…Hlypothermiia System Classification name: System, Thermal, Regulating, DWJ Equivalent marketed device: Blair Hugger temperature management system (K02 1473, KOOI1 149, K960 167, K903360, K873745). Device description: The Bair Hugger temperature management system consists of a portable forced-air temperat…
Augustine Medical, Inc.1996—
*K903360Bair Hugger (R) Patient Warming System-Modification
Summary page 1
…iia System Classification name: System, Thermal, Regulating, DWJ Equivalent marketed device: Blair Hugger temperature management system (K02 1473, KOOI1 149, K960 167, K903360, K873745). Device description: The Bair Hugger temperature management system consists of a portable forced-air temperature manag…
Augustine Medical, Inc.1990—
*K873745Bair Hugger (TM) - Patient Warming System
Summary page 1
…m Classification name: System, Thermal, Regulating, DWJ Equivalent marketed device: Blair Hugger temperature management system (K02 1473, KOOI1 149, K960 167, K903360, K873745). Device description: The Bair Hugger temperature management system consists of a portable forced-air temperature management uni…
Augustine Medical, Inc.1987—

Also cleared against K021473: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc.20066
K140635Cocoon Convective Warming SystemCare Essentials Pty, Ltd.20140

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K053645 (Arizant Healthcare, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K021473.

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.

Also cleared against K021473

1 other device cites the same predicate.

  • K162679IOB Temperature Management SystemIob Medical, Inc. · 2017

More from Arizant Healthcare, Inc.

6 FDA decisions under this applicant name. See the company

  • K1204123M Spoton Temperature Monitoring SystemArizant Healthcare, Inc. · 20121 recall
  • K082217Ranger Rapid Flow Blood/Fluid Warming SystemArizant Healthcare, Inc. · 2008
  • K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 20061 recall
  • K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 20066 recalls
  • K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 20064 recalls

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/K041686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041686: Bair Hugger 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/K041686

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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