# DWJ: System, Thermal Regulating

- Device class: 2; regulation: 21 CFR 870.5900; FDA's rule: 510(k) required
- FDA decisions: 161
- 510(k) review time 2021–2025: median 120 days (middle half 42–194)
- Recalls: 48 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 3
- 2019: 2
- 2020: 5
- 2021: 2
- 2022: 2
- 2023: 6
- 2024: 2
- 2025: 3
- 2026: 5

## Most-cited predicates
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank (2000), cited by 10
- K811742: Hemotherm Model 400 (1981), cited by 5
- K010338: Artic Sun Temperature Management System, Model 200 (2001), cited by 5
- K912051: Medi-Therm (Mta-5900) & Detachable Hoses (1991), cited by 5
- K011907: Snuggle Warm 4000 Convective Warming System (2001), cited by 5
- K052392: Hot Dog Patient Warming System (2006), cited by 5
- K991684: Chillbuster Portable Electric Blanket System, Model 8001 (2000), cited by 4
- K003349: Allon 2001 Modified (2000), cited by 4
- K011859: Klimamed Thermal Mat & Controller 95 and 55 Watts (2002), cited by 4
- K960167: System, Thermal Regulating 74-DWJ (1996), cited by 4

Source page: https://510kreport.com/product-code/DWJ
Data by year (CSV): https://510kreport.com/product-code/DWJ.csv