# DRR: Amplifier And Signal Conditioner, Biopotential

- Device class: 2; regulation: 21 CFR 870.2050; FDA's rule: 510(k) required
- FDA decisions: 24
- 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)
- 1980: 2
- 1981: 2
- 1986: 1
- 1988: 1
- 1989: 2
- 1991: 2
- 1992: 1
- 1993: 1
- 1997: 1
- 2002: 1

## Most-cited predicates
- K971570: Epxpress System (Timberwolf Revision) /000391 (1997), cited by 1
- K910307: Cardiolab Amplifier Module (Cam) (1991), cited by 1
- K874441: Bard Biopotential Amplifier (1988), cited by 1

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