# K033298: SPO2.Com Oximetry Sensors, Multiple Models

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Dec 12, 2003 after 59 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 K962603 (1997). 8 ancestors in all.
95 later devices descend from it; 5 cite it directly.
3 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.

## Most influential descendants
- K041815: LNCS Oximetry Sensors (2004), 86 descendants of its own
- K051212: Modification to LNCS Oximetry Sensors (2005), 85 descendants of its own
- K101896: Masimo LNCS/M-LNCS Oximetry Sensors (2010), 62 descendants of its own
- K111888: Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors (2011), 59 descendants of its own
- K100617: Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D (2010), 39 descendants of its own

## Indications for use
The SPO2.COM Sensors and Cables are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SPO2 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/K033298
Methodology: https://510kreport.com/methodology