# K962603: Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Feb 6, 1997 after 219 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,002 later devices descend from it; 2 cite it directly.
47 of 1,003 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
- K973887: Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables (1998), 1,000 descendants of its own
- K982255: Model 2000 Pulse Oximeter (1998), 816 descendants of its own
- K991823: N-395 Pulse Oximeter, Model N-395 (1999), 785 descendants of its own
- K993637: N-395 Pulse Oximeter, with Extended Device Claims (1999), 715 descendants of its own
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) (2002), 548 descendants of its own

Source page: https://510kreport.com/device/K962603
Methodology: https://510kreport.com/methodology