Data / Medical devices / United States / Augustine Temperature Management, LLC
Augustine Temperature Management, LLC: FDA-registered device maker in Minnetonka, MN, United States, 7 510(k) clearances
Augustine Temperature Management, LLC is registered with the FDA (registration 3005857264) in Minnetonka, MN, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 18, 2024. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005857264
- Address
- 15305 Minnetonka Blvd, Minnetonka, MN, United States, 55345
- Owner or operator
- Augustine Temperature Management, LLC (9076948)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 16, 2005
- Registered through
- 2026
- Brand names listed
- HOT DOG PATIENT WARMING, Hot Dog Multi Function Controller, Hot Dog Patient Warming Mattress System, Hot Dog Patient Warming System, HotDog Temperature Management Controller, HotDog Warming Mattress + Return Electrode, WaffleGrip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 18, 2024 | K232627 | HotDog Warming Mattress + Return Electrode | DWJ | Substantially Equivalent | Augustine Temperature Management, LLC | accessdata.fda.gov |
| June 29, 2023 | K230866 | HotDog Warming Mattress + Return Electrode | DWJ | Substantially Equivalent | Augustine Temperature Management, LLC | accessdata.fda.gov |
| September 11, 2020 | K201779 | HotDog Temperature Management Controller | DWJ | Substantially Equivalent | Augustine Temperature Management | accessdata.fda.gov |
| November 23, 2011 | K112488 | HOTDOG PATIENT WARMING SYSTEM | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| June 3, 2010 | K094056 | HOTDOG MULTI FUNCTION CONTROLLER | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| December 10, 2009 | K092807 | HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| May 4, 2006 | K052392 | HOT DOG PATIENT WARMING SYSTEM | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 16, 2024 | 96155 | Class II | Ongoing | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia | 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 connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU. | accessdata.fda.gov |
| December 4, 2024 | 95703 | Class II | Ongoing | 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 and Mattresses. | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST". | accessdata.fda.gov |
| February 15, 2024 | 95914 | Class II | Ongoing | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses. | Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact. | accessdata.fda.gov |
| March 14, 2022 | 95913 | Class II | Completed | 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 and Mattresses. | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST". | accessdata.fda.gov |
Compare with other makers
- All makers of Support, Patient Position
- All makers of System, Thermal Regulating
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated February 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.