# DPZ: Oximeter, Ear

- Device class: 2; regulation: 21 CFR 870.2710; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 3 (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)
- 1981: 1
- 1985: 2
- 1986: 1
- 1992: 1
- 1994: 2
- 2001: 2
- 2004: 2

## Most-cited predicates
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 (2004), cited by 4
- K944760: Dura-Y Oxygen Transducer, Ear Clip (1994), cited by 3
- K850494: Ohmeda Biox 3700 Pulse Oximeter (1985), cited by 2
- K010718: Flexi-Site SP02 Ear Sensor (2001), cited by 1
- K042675: Flexi-Stat SP02 Ear Sensor (2004), cited by 1

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