# IMC: Bath, Paraffin

- Device class: 2; regulation: 21 CFR 890.5110; FDA's rule: 510(k) exempt
- FDA decisions: 12
- Recalls: 0 (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)
- 1977: 1
- 1983: 1
- 1984: 1
- 1986: 2
- 1998: 1
- 1999: 1
- 2000: 1
- 2001: 1
- 2002: 2
- 2009: 1

## Most-cited predicates
- K001860: Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra (2000), cited by 2
- K022626: Moisturestay (Revlon) (2002), cited by 1

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