510(k) Report

510(k) · Cleared

Cleared

Modification of Bair Hugger Patient Warming System

K933726510(k) TraditionalCleared Jan 28, 1994179-day reviewClass I21 CFR 890.5950

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

Augustine Medical, Inc. · LHC Warmer, Irrigation Solution

Cleared on Jan 28, 1994 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.

Decided
Jan 28, 1994
Review
179 days
Class
Class I
Product code
LHC
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2010: 1 descendant cleared2008: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared2017: 1 descendant cleared2026: 2 descendants cleared2014: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK933726 Modification of Bair Hugger Patient Warming SystemAugustine Medical, Inc. · 1994
  2. Descendant · cites it directly · 8 of its ownK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 7 of its ownK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
  4. Descendant · 2 generations on · 4 of its ownK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12010: 12014: 12016: 12017: 12021: 12026: 2
2006high 2 (2026) · low 0 (2007)2026

Class I recalls in this family

  • K072080 Normoflo Irrigation Fluid Warmer, Models H-1100…2 generations on · 2008

Most influential descendants

Showing 5 of 9 · See all
  • K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · cites it directly8descendants
  • K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Smiths Medical Asd, Inc. · 2008 · 2 generations on7descendants
  • K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · 2 generations on4descendants
  • K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · 3 generations on3descendants
  • K172048FluidSmartThermedx, LLC · 2017 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933726Modification of Bair Hugger Patient Warming SystemAugustine Medical, Inc.1994—
+1K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc.20061
+2K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation…Smiths Medical Asd, Inc.2008Class I
+2K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC20102
+3K133799Thermedx Fluid Managment SystemThermedx, LLC20142
+3K172048FluidSmartThermedx, LLC20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200811
201010
201410
201610
201710
202110
202620
FIG. 1 — Lineage of K933726, 1994–2026Source: 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc.20068

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K060939 (Arizant Healthcare, Inc., 2006) has gone furthest, with 8 descendants of its own.

How does its category compare?

All LHC devices

LHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LHC

2in 2016

2008: 12009: 12014: 22015: 12016: 2
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHC

Too few LHC 510(k)s in any year since 2007 to give a median.

Recalls per year · LHC

8in 2015

2015: 8
2007high 8 (2015) · low 0 (2007)2026

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

Adverse event reports per year · LHC

6in 2025

2007: 32008: 52009: 22010: 12011: 22012: 52013: 22014: 42015: 132016: 692017: 332018: 302019: 82020: 42021: 52022: 12024: 52025: 6
2007high 69 (2016) · low 0 (2023)2025

MAUDE reports naming product code LHC, 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
20070—03
20081—05
20091—02
20100—01
20110—02
20120—05
20130—02
20142—04
20151—813
20162—069
20170—033
20180—030
20190—08
20200—04
20210—05
20220—01
20230—00
20240—05
20250—06
20260—0—

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
  • 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

Recent decisions in LHC

The LHC category page

  • K153713Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016
  • K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc. · 2016
  • K150190IntraTemp Solution WarmerEcolab, Inc. · 2015
  • K142173Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014
  • K142080Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,SkirtedEcolab, Inc. · 20149 recalls

https://510kreport.com/device/K933726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933726: Modification of Bair Hugger Patient Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933726

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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