# K110723: M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Jul 28, 2011 after 134 days
- Product code: NLF (Oximeter, Reprocessed)
- 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: 17 generations back to K941811 (1994). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101896: Masimo LNCS/M-LNCS Oximetry Sensors, Masimo Corporation (2010) Summary page 1.
- K083622: LNCS Oximetry Sensors, Masimo Corporation (2009) Summary page 1.
- K083719: LNCS Oximetry Sensors, Masimo Corporation (2009) Summary page 1.

## Indications for use
The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP0 2) and pulse rate (measured by an SP02 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. The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP0 2) and pulse rate (measured by an SP02 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are welt or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K110723
Methodology: https://510kreport.com/methodology