# K032551: Masimo Lnop-TF-I Resuable Transflectance Sensor

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Feb 19, 2004 after 184 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). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000126: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia, Masimo Corp. (2000)
- K021089: Oximax Max-Fast Adhesive Forehead Sensor, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K160940: Masimo Disposable Transflectance Forehead Sensor (2016), 0 descendants of its own

## Indications for use
The following additional Masimo Sensor is indicated for the continuous noninvasive functional oxygen saturation of arterial hemoglobin (Sp0 2) and pulse rate: Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K032551
Methodology: https://510kreport.com/methodology