510(k) Report

FDA applicant

Augustine Medical, Inc.

Eden Prairie, MN25 decisions1987–20024 recalls

FDA records 25 decisions for Augustine Medical, Inc. (Eden Prairie, MN) from 1987 to 2002: 25 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and CCW (Laryngoscope, Rigid). Its devices cite 6 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices, 1 Class I.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Augustine Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Augustine Medical, Inc. since 2007.

Recalls per year

1in 2025

2007: 22025: 1, 1 Class I
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Augustine Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Augustine Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DWJSystem, Thermal Regulating12decisions
  • CCWLaryngoscope, Rigid5decisions
  • BSRStylet, Tracheal Tube3decisions
  • MSADressing, Wound And Burn, Occlusive, Heated2decisions
  • BSBWarmer, Blood, Non-Electromagnetic Radiation1decision
  • JOWSleeve, Limb, Compressible1decision

Also: LHC (1).

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001149Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair…Augustine Medical, Inc. · 200010cite it
  • K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 19987cite it
  • K960167System, Thermal Regulating 74-DWJAugustine Medical, Inc. · 19964cite it
  • K021473Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 20022cite it
  • K903360Bair Hugger (R) Patient Warming System-ModificationAugustine Medical, Inc. · 19902cite it
  • K873745Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 19872cite it

What has FDA decided for it lately?

  • 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
  • K963293Augustine Medical Wound Care System Model 68XXXAugustine Medical, Inc. · 1997
  • K963672Model 90022 Rolling StandAugustine Medical, Inc. · 1997
  • K960167System, Thermal Regulating 74-DWJAugustine Medical, Inc. · 1996

All 25 as Augustine Medical, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K9737413M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370Apr 10, 2025Class I
  • K973741Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with…Jun 26, 2007
  • K973741Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with…Jun 26, 2007
  • K001149Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use…Mar 11, 2005

Other applicant names beginning “Augustine”

FDA records each applicant name separately; these may or may not be the same firm.

Augustine Temperature Management, LLC 5Augustine Biomedical & Design, LLC 4