# K853990: OSM3 Hemoximeter

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Dec 30, 1985 after 94 days
- Product code: JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide)
- Device class: 1
- Regulation: 21 CFR 862.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
246 later devices descend from it; 4 cite it directly.
2 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042536: Masimo Set Rad 57 Pulse CO-Oximeter (2005), 244 descendants of its own
- K053477: Masimo Set Rad 57 CM and M Pulse CO-Oximeters (2006), 226 descendants of its own
- K061204: Masimo Set Radical 7 Pulse CO-Oximeter (2006), 225 descendants of its own
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter (2008), 219 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own

Source page: https://510kreport.com/device/K853990
Methodology: https://510kreport.com/methodology