# K103686: STAR 50 N

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Mar 15, 2011 after 88 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941811 (1994). 85 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080173: STAR 55, Larsen & Toubro Limited (2008) Summary page 2.
- K093017: Stellar 300, Larsen & Toubro Limited (2010) Summary page 2.

## Most influential descendants
- K132033: BM3/BM3 Plus (2013), 0 descendants of its own

## Indications for use
The Star SON multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 5 lead), SpO12, Respiration, Temperature, external optional Capnography (C02) It can also display the digital values of HR/PR, SP0 2, RR, Non-invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EyCO2, and FiCO2. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K103686
Methodology: https://510kreport.com/methodology