# K973887: Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Jan 8, 1998 after 86 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
Longest line of descent: 1 generation back to K962603 (1997). 1 ancestor in all.
1,000 later devices descend from it; 2 cite it directly.
47 of 1,002 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962603: Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables, Masimo Corp. (1997) Summary page 1.

## Most influential descendants
- 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
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis (1999), 477 descendants of its own

## Indications for use
Masimo SET® MS-1P Pulse Oximeter and the LNOP® Series of Sensors and PC Series of Patient Cables are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO,) and pulse rates during both no motion and patient motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment. The Masimo LNOP® Series of Sensors are indicated for the following: A single use oximetry sensor intended for adults and pediatrics greater than 30 kg A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg A single use oximetry sensor intended for neonates greater than 2,000 gms A single use oximetry sensor intended for neonates less than 2,000 gms A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® MS-1P Pulse Oximeter.

Source page: https://510kreport.com/device/K973887
Methodology: https://510kreport.com/methodology