# GLY: Oximeter To Measure Hemoglobin

- Device class: 2; regulation: 21 CFR 864.7500; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 0 (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)
- 1989: 1
- 1996: 2
- 1999: 1
- 2005: 1

## Most-cited predicates
- K952725: Multicheck (1996), cited by 1

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