# K042346: LNCS Oximetry Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Sep 20, 2004 after 21 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: 5 generations back to K962603 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 1.
- K033298: SPO2.Com Oximetry Sensors, Multiple Models, Masimo Corp. (2003) Summary page 1.

## Most influential descendants
- K050068: Lnopv AD-L and PD-L Oximetry Sensors (2005), 0 descendants of its own

## Indications for use
The LNOPv and LNOP x Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K042346
Methodology: https://510kreport.com/methodology