# Augustine Temperature Management, LLC

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 5 (2020–2024): 5 510(k) clearances
- Names in FDA's records: Augustine Temperature Management, LLC (3); Augustine Temperature Management (2)
- Product codes: DWJ (4), GEI (1)
- 510(k) review time since 2016: median 92 days, against 42 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Augustine Biomedical & Design, LLC: 2 (https://510kreport.com/company/augustine-biomedical-design)
- Megadyne Medical Products, Inc.: 1 (https://510kreport.com/company/megadyne-medical-products)

## Its most-cited devices
- K201779: HotDog Temperature Management Controller (2020), cited by 1
- K220941: HotDog Temperature Management System (2022), cited by 1
- K230866: HotDog Warming Mattress + Return Electrode (2023), cited by 1

## Recent decisions
- K232627: HotDog Warming Mattress + Return Electrode (Apr 18, 2024)
- K230866: HotDog Warming Mattress + Return Electrode (Jun 29, 2023)
- K220941: HotDog Temperature Management System (Sep 23, 2022)
- K210727: HotDog Warming Mattress + Return Electrode (Feb 1, 2022)
- K201779: HotDog Temperature Management Controller (Sep 11, 2020)

Source page: https://510kreport.com/company/augustine-temperature-management