Chrysalis Intelligence · Sponsors · Augustine Temperature Management, LLC

Augustine Temperature Management, LLC

Minneapolis, MN, US · 5 510(k) clearances · 13 recalls

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Total clearances
5
2020-09-11 → 2024-04-18
Last 12 months
0
Product codes
2
Most recent
2024-04-18
Name variants in FDA filings: Augustine Temperature Management, LLC / Augustine Temperature Management
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DWJ System, Thermal Regulating Class II Cardiovascular 4 2024-04-18
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 1 2022-02-01
Safety

Recalls (13)

Class I (serious)
0
Risk of injury / death
Total recalls
13
Currently ongoing
8
Most recent
2024-12-16
DateSeverityStatusRecall # ProductCodeReason
2024-12-16 Class II Ongoing Z-1199-2025 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypo… — There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connec…
2024-12-16 Class II Ongoing Z-1198-2025 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hyp… — There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connec…
2024-12-16 Class II Ongoing Z-1197-2025 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypo… — There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connec…
2024-12-04 Class II Ongoing Z-0702-2025 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses… — Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to…
2024-12-04 Class II Ongoing Z-0701-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC7… — Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to…
2024-12-04 Class II Ongoing Z-0700-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W… — Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to…
2024-02-15 Class II Ongoing Z-1172-2025 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming … — Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
2024-02-15 Class II Ongoing Z-1171-2025 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming… — Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
2022-03-14 Class II Completed Z-0843-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; … — HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error co…
2022-03-14 Class II Completed Z-0842-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; … — HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error co…
2022-03-14 Class II Completed Z-0841-2025 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses… — HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error co…
2022-03-14 Class II Completed Z-0840-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W… — HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error co…
2022-03-14 Class II Completed Z-0839-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W… — HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error co…
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2024-04-18 K232627 HotDog Warming Mattress + Return Electrode DWJ Class II Cardiovascular
2023-06-29 K230866 HotDog Warming Mattress + Return Electrode DWJ Class II Cardiovascular
2022-09-23 K220941 HotDog Temperature Management System DWJ Class II Cardiovascular
2022-02-01 K210727 HotDog Warming Mattress + Return Electrode GEI Class II General, Plastic Surgery
2020-09-11 K201779 HotDog Temperature Management Controller DWJ Class II Cardiovascular
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence