510(k) Report

510(k) · Cleared

Recalled · 2005

Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank

K001149510(k) TraditionalCleared Sep 6, 2000149-day reviewClass II21 CFR 870.5900Recalls 1

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 Sep 6, 2000 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it. It has been recalled once.

Decided
Sep 6, 2000
Review
149 days
Class
Class II
Product code
DWJ
Recalls
1
Predicates
0

57 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2006: 4 descendants cleared2014: 2 descendants cleared2010: 3 descendants cleared2004: 2 descendants cleared2011: 2 descendants cleared2017: 4 descendants cleared2008: 1 descendant cleared2020: 4 descendants cleared2009: 2 descendants cleared2012: 1 descendant cleared2018: 1 descendant cleared2021: 2 descendants cleared2013: 3 descendants cleared2026: 4 descendants cleared2022: 3 descendants cleared2023: 7 descendants cleared2024: 4 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2019: 1 descendant cleared2025: 4 descendants cleared200020052010201520202025
  1. This deviceK001149 Augustine Medical Bair Huuger, Model 750 Total Temperature…Augustine Medical, Inc. · 2000
  2. Descendant · cites it directly · 35 of its ownK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
  3. Descendant · 2 generations on · 20 of its ownK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
  4. Descendant · 3 generations on · 19 of its ownK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
  5. Descendant · 4 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
  6. Descendant · 5 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2004: 22006: 42008: 12009: 22010: 32011: 22012: 12013: 32014: 22015: 22016: 12017: 42018: 12019: 12020: 42021: 22022: 32023: 72024: 42025: 42026: 4
2004high 7 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 57 · See all
  • K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006 · cites it directly35descendants
  • K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010 · 2 generations on20descendants
  • K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013 · 3 generations on19descendants
  • K142732T3 SoftwareEtiometry, Inc. · 2015 · 4 generations on18descendants
  • K151715T3 SoftwareEtiometry, Inc. · 2015 · 5 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001149Augustine Medical Bair Huuger, Model 750 Total Temperature Management…Augustine Medical, Inc.2000—
+1K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC2006—
+2K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG2010—
+3K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc.2013—
+4K142732T3 SoftwareEtiometry, Inc.2015—
+5K151715T3 SoftwareEtiometry, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200640
200810
200920
201030
201120
201210
201330
201420
201520
201610
201740
201810
201910
202040
202120
202230
202370
202440
202540
202640
FIG. 1 — Lineage of K001149, 2000–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC200635
K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc.20047
K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company20173
K101705Mistral-Air Warming SystemThe Surgical Company International B.V.20102
K062794PRN Thermalcare, Model 3000American Healthcare Products, Inc.20062
K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc.20141
K162562Opt-Shield Air, Supine; Opt-Shield, LithotomyBcg Medical, LLC20170
K102856Sirocco Thermal Regulating SystemGalmaz Biotech S.L.20110
K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical20080
K040440HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets)Http Hypothermia Therapy20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2005Not classifiedZ-0855-05OtherAir channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K052392 (Augustine Biomedical & Design, LLC, 2006) has gone furthest, with 35 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—

More from Augustine Medical, Inc.

25 FDA decisions under this applicant name. See the company

  • K021473Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
  • K020077Modification to Augustine Medical Wound Care System, Model 68XXXAugustine Medical, Inc. · 2002
  • 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/K001149 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001149

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026