# DOF: Lead, Atomic Absorption

- Device class: 2; regulation: 21 CFR 862.3550; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 10 (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)
- 1985: 1
- 1994: 1
- 1997: 1
- 2005: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K123563: Leadcare (R)  Ultra (TM) Blood Lead Testing System (2013), cited by 1
- K052549: Leadcare II Blood Lead Testing System (2005), cited by 1
- K971640: Leadcare Blood Lead Testing System (1997), cited by 1

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