# IRT: Pad, Heating, Powered

- Device class: 2; regulation: 21 CFR 890.5740; FDA's rule: 510(k) exempt
- FDA decisions: 42
- 510(k) review time 2021–2025: median 183 days (middle half 152–214)
- Recalls: 9 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 3
- 1996: 4
- 1997: 1
- 2008: 1
- 2011: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K963824: Li's Itch Stopper (1996), cited by 2
- K924800: Mosist Heat Pad with Automatic Off (1993), cited by 2
- K072534: Bio-Mat 2000 (2008), cited by 2
- K924799: Moist Heat Pad (1993), cited by 2
- K963887: PT-Pac Portable Heating Pad (1997), cited by 1
- K111273: Fir Heat Theraphy Sysyems (2011), cited by 1
- K220514: bite away neo (2022), cited by 1
- K160943: Bite Away (2016), cited by 1

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