# K051439: Lnop Blue Oximetry Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jul 15, 2005 after 43 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: 4 generations back to K000126 (2000). 5 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042536: Masimo Set Rad 57 Pulse CO-Oximeter, Masimo Corporation (2005) Summary page 1.
- (no number) Masimo LNOP Inf-L sensor: named in the summary without a submission number

## Most influential descendants
- K062268: Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03 (2006), 38 descendants of its own
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model (2010), 37 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own

## Indications for use
The LNOP Blue Sensors are indicated for the continuous noninvasive monitoring of fallutional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K051439
Methodology: https://510kreport.com/methodology