510(k) Report

FDA applicant

Augustine Biomedical & Design, LLC

Eden Prairie, MN4 decisions2006–20110 recalls

FDA records 4 decisions for Augustine Biomedical & Design, LLC (Eden Prairie, MN) from 2006 to 2011: 4 510(k) clearances. All are in product code DWJ (System, Thermal Regulating). Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

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 Biomedical & Design, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12010: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Augustine Biomedical & Design, LLC’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 Regulating4decisions

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 4 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.

  • K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 20065cite it
  • K112488Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC · 20113cite it
  • K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC · 20092cite it
  • K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 20101cites it

What has FDA decided for it lately?

  • K112488Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC · 2011
  • K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
  • K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC · 2009
  • K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006

All 4 as Augustine Biomedical & Design, LLC →

Other applicant names beginning “Augustine”

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

Augustine Medical, Inc. 25Augustine Temperature Management, LLC 5