# K041815: LNCS Oximetry Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Jul 29, 2004 after 23 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: 13 generations back to K941811 (1994). 64 ancestors in all.
86 later devices descend from it; 9 cite it directly.
0 of 151 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.
- K040259: Masimo Set Intellivue Pulse Oximeter Module, Masimo Corp. (2004) Summary page 1.
- K033298: SPO2.Com Oximetry Sensors, Multiple Models, Masimo Corp. (2003) Summary page 1.

## Most influential descendants
- K051212: Modification to LNCS Oximetry Sensors (2005), 85 descendants of its own
- K101896: Masimo LNCS/M-LNCS Oximetry Sensors (2010), 62 descendants of its own
- K111888: Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors (2011), 59 descendants of its own
- K100617: Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D (2010), 39 descendants of its own
- K111621: Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors (2011), 38 descendants of its own

## Indications for use
The LNCS Sensors and Cables are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an SP 2 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/K041815
Methodology: https://510kreport.com/methodology