# KTB: Device, Iontophoresis, Specific Uses

- Device class: 2; regulation: 21 CFR 890.5525; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1984: 1
- 1985: 1
- 1990: 1
- 1996: 1
- 1998: 1
- 1999: 1
- 2000: 2
- 2001: 1
- 2003: 3
- 2018: 1

## Most-cited predicates
- K974855: Phoresor II, Model PM900 (1998), cited by 4
- K031115: RH-900 (2003), cited by 2
- K033192: RH-950 (2003), cited by 2
- K853973: Wescor Model 3700 Webster Sweat Inducer (1985), cited by 1

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