# NDW: Assay, Porphyrin, Spectrophotometry, Lithium

- Device class: 2; regulation: 21 CFR 862.3560; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 266 days (middle half 266–266)
- Recalls: 4 (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)
- 2001: 1
- 2005: 1
- 2007: 2
- 2008: 1
- 2011: 1
- 2025: 1

## Most-cited predicates
- K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901 (2001), cited by 3
- K050374: Advia Ims Lithium Assay (2005), cited by 1

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