# K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Oct 8, 1999 after 87 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962603 (1997). 7 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis, Masimo Corp. (1999) Summary page 1.
- K923682: Model M1032A Vuelink Interface Plug-in Module, Hewlett-Packard Co. (1992) Summary page 1.
- K971273: Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF, Bio-Tek Instruments, Inc. (1997) Summary page 1.

## Most influential descendants
- K062144: Escort M8 Vital Signs Patient Monitor, Model 3810 (2006), 11 descendants of its own
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software (2009), 10 descendants of its own
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device (2004), 5 descendants of its own
- K130740: Nightingale Monitoring System (2013), 3 descendants of its own
- K123556: Mortara Surveyor Patient Monitor (2013), 2 descendants of its own

## Recalls of this device
- Jun 10, 2005 · Not classified · Z-0933-05: Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.

## Indications for use
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO, sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospisals, hospital-type facilities, and home environments. In addition the Masimo SBT® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO, sensor) to multi-parameter devices for display on those devices. The Masima LNOP™ Series of Sensors are indicated for the following: A single use oximetry sensor intended for adults and pediatrics greater than 30 kg A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShare™. The Masimo MC connecting cable is indicated for connection to Nellcor sensor compatible cables.

Source page: https://510kreport.com/device/K992340
Methodology: https://510kreport.com/methodology