Augustine Temperature Management, LLC
FDA Regulatory Profile
Augustine Temperature Management, LLC appears in FDA public data with 13 recalls, 5 510(k) clearances, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1198-2025, Class II) was initiated on December 16, 2024. Its most recent 510(k) clearance was granted on April 18, 2024.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1198-2025 | Class II | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to | December 16, 2024 |
| Z-1199-2025 | Class II | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to p | December 16, 2024 |
| Z-1197-2025 | Class II | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to p | December 16, 2024 |
| Z-0701-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Model | December 4, 2024 |
| Z-0702-2025 | Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Bla | December 4, 2024 |
| Z-0700-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Mod | December 4, 2024 |
| Z-1171-2025 | Class II | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conj | February 15, 2024 |
| Z-1172-2025 | Class II | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conju | February 15, 2024 |
| Z-0842-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Mod | March 14, 2022 |
| Z-0839-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Mod | March 14, 2022 |
| Z-0840-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Mod | March 14, 2022 |
| Z-0841-2025 | Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Bla | March 14, 2022 |
| Z-0843-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Mod | March 14, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232627 | HotDog Warming Mattress + Return Electrode | April 18, 2024 |
| K230866 | HotDog Warming Mattress + Return Electrode | June 29, 2023 |
| K220941 | HotDog Temperature Management System | September 23, 2022 |
| K210727 | HotDog Warming Mattress + Return Electrode | February 1, 2022 |
| K201779 | HotDog Temperature Management Controller | September 11, 2020 |