# K050068: Lnopv AD-L and PD-L Oximetry Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Feb 9, 2005 after 28 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: 6 generations back to K962603 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042346: LNCS Oximetry Sensors, Masimo Corporation (2004) Summary page 1.

## Indications for use
The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric 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/K050068
Methodology: https://510kreport.com/methodology