# LNW: Paper, Obstetric Ph

- Device class: 1; regulation: 21 CFR 862.1550; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 1 (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
- 1996: 1
- 2001: 1
- 2003: 1

## Most-cited predicates
- K960648: Phem-Chek (1996), cited by 2
- K012230: Phem-Alert (2001), cited by 1
- K850858: OB-PH - PH Test Paper (1985), cited by 1

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