# K083622: LNCS Oximetry Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Apr 2, 2009 after 115 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: 16 generations back to K941811 (1994). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041815: LNCS Oximetry Sensors, Masimo Corp. (2004) Summary page 1.
- K051212: Modification to LNCS Oximetry Sensors, Masimo Corporation (2005) Summary page 1.
- K060143: LNCS and SPO2.Com Sensors, Masimo Corporation (2006) Summary page 1.

## Most influential descendants
- K110723: M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry Sensors (2011), 0 descendants of its own

## Indications for use
The LNCS Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp0 2) 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/K083622
Methodology: https://510kreport.com/methodology