510(k) Report

FDA applicant

Augustine Temperature Management, LLC

Minneapolis, MN5 decisions2020–20248 recalls

FDA records 5 decisions for Augustine Temperature Management, LLC (Minneapolis, MN) from 2020 to 2024: 5 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 42 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Augustine Temperature Management”.

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 Temperature Management, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12022: 22023: 12024: 1
2020high 2 (2022) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

7in 2024

2022: 12024: 7
2020high 7 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Augustine Temperature Management, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWJSystem, Thermal Regulating4decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 92 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 42 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201779HotDog Temperature Management ControllerAugustine Temperature Management · 20201cites it
  • K220941HotDog Temperature Management SystemAugustine Temperature Management · 20221cites it
  • K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 20231cites it

What has FDA decided for it lately?

  • K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2024
  • K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 20234 recalls
  • K220941HotDog Temperature Management SystemAugustine Temperature Management · 20224 recalls
  • K210727HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 20222 recalls
  • K201779HotDog Temperature Management ControllerAugustine Temperature Management · 20204 recalls

All 3 as Augustine Temperature Management, LLC →All 2 as Augustine Temperature Management →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K230866Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF…Dec 16, 2024Class II
  • K230866Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF…Dec 16, 2024Class II
  • K201779Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…Dec 4, 2024Class II
  • K201779Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…Dec 4, 2024Class II
  • K201779Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with…Dec 4, 2024Class II
  • K210727Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138…Feb 15, 2024Class II

Other applicant names beginning “Augustine”

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

Augustine Medical, Inc. 25Augustine Biomedical & Design, LLC 4