# K992238: Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci, Patient Cable (PC04, PC08, PC12)

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corp.
- Decided: Oct 8, 1999 after 98 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: 3 generations back to K962603 (1997). 3 ancestors in all.
28 later devices descend from it; 3 cite it directly.
1 of 32 devices in its family (counting itself) has 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.

## Most influential descendants
- K014255: Dinamap Procare Series Monitor; Model 100, 200, 300, 400 (2002), 22 descendants of its own
- K022193: Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N (2002), 21 descendants of its own
- K073203: Carescape V100 (2007), 20 descendants of its own
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own

## Indications for use
The Masimo SET® Radical Pulse Oximeter and accessories ate 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 and accessaries 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 hospitals, hospital-type facilities, and home environments. The Masimo 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.

Source page: https://510kreport.com/device/K992238
Methodology: https://510kreport.com/methodology