# DOP: Mass Spectrometer, Clinical Use

- Device class: 1; regulation: 21 CFR 862.2860; FDA's rule: 510(k) exempt
- FDA decisions: 10
- Recalls: 6 (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: 2
- 1981: 1
- 1985: 1
- 1987: 1
- 1988: 3
- 1997: 1
- 1999: 1

## Most-cited predicates
- K974322: Abca-NT Gas Isotope Ratio Mass Spectrometer System (1997), cited by 2

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