# K060143: LNCS and SPO2.Com Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jun 16, 2006 after 148 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: 15 generations back to K941811 (1994). 66 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033298: SPO2.Com Oximetry Sensors, Multiple Models, Masimo Corp. (2003) Summary page 1.
- K041815: LNCS Oximetry Sensors, Masimo Corp. (2004) Summary page 1.
- K051212: Modification to LNCS Oximetry Sensors, Masimo Corporation (2005) Summary page 1.

## Most influential descendants
- K081238: Reprocessed Masimo Pulse Oximeter Sensors (2008), 3 descendants of its own
- K211140: Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 (2022), 2 descendants of its own
- K083719: LNCS Oximetry Sensors (2009), 2 descendants of its own
- K222019: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (2022), 1 descendant of its own
- K083622: LNCS Oximetry Sensors (2009), 1 descendant of its own

## Indications for use
The LNCS Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp 0 2) and pulse rate (measured by an SpO 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. The SP02.COM Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO 2 sensor) for use with adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K060143
Methodology: https://510kreport.com/methodology