Company ยท US
Augustine Temperature Management, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2024. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 2024 | K232627 | HotDog Warming Mattress + Return Electrode Augustine Temperature Management, LLC | DWJ |
| Jun 29, 2023 | K230866 | HotDog Warming Mattress + Return Electrode Augustine Temperature Management, LLC | DWJ |
| Sep 23, 2022 | K220941 | HotDog Temperature Management System Augustine Temperature Management | DWJ |
| Feb 1, 2022 | K210727 | HotDog Warming Mattress + Return Electrode Augustine Temperature Management, LLC | GEI |
| Sep 11, 2020 | K201779 | HotDog Temperature Management Controller Augustine Temperature Management | DWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia Open, Classified |
DWJ | K230866 |
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia Open, Classified |
DWJ | None listed |
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia Open, Classified |
DWJ | K230866 |
| Feb 14, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | K210727 K230866 |
| Feb 14, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136
used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | K210727 K230866 |
| Jan 10, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) WC77V;
2) WC77V-DEMO;
3) WC77V-R;
used in conjunction with Warming Blankets and Mattr Completed |
DWJ | None listed |
| Jan 10, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) WC71V;
2) WC71V-DEMO;
3) WC71V-R;
used in conjunction with Warming Blankets and Ma Completed |
DWJ | None listed |
| Jan 10, 2025 | Augustine Temperature Management, LLC Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses. Completed |
DWJ | None listed |
| Jan 10, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC77,
2) Model # WC77D (Demo),
3) Model # WC77R (Refurbished); used in conjuncti Completed |
DWJ | None listed |
| Jan 10, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC71,
2) Model # WC71R (refurbished); used in conjunction with Warming Blankets a Completed |
DWJ | K201779 K220941 |
| Dec 18, 2024 | Augustine Temperature Management, LLC Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | K201779 K220941 |
| Dec 18, 2024 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models:
1) Model # WC77,
2) Model # WC77D (Demo),
3) Model # WC77R (Refurbished); used in conjunction Open, Classified |
DWJ | K201779 K220941 |
| Dec 18, 2024 | Augustine Temperature Management, LLC Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC71,
2) Model # WC71R (refurbished); used in conjunction with Warming Blankets a Open, Classified |
DWJ | K201779 K220941 |