# JKS: Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

- Device class: 1; regulation: 21 CFR 862.3220; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 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)
- 1978: 1
- 1983: 3
- 1985: 1
- 1986: 2
- 1995: 1

## Most-cited predicates
- K853990: OSM3 Hemoximeter (1985), cited by 4
- K951485: Avoximeter 4000 (1995), cited by 1
- K832066: Control 282 (1983), cited by 1

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