# K150512: STAR 90

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Pvt, Ltd.
- Decided: Jun 17, 2015 after 110 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: 26 generations back to K941811 (1994). 172 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093268: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 4.

## Cited in the summary but kept off the family tree
- K080073: S-Test Creatinine (Cre), Alfa Wassermann, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K172147: STAR 65 (2018), 0 descendants of its own

## Indications for use
The STAR 90 multi-paramet er Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient’s vital signs at the bedside or during intra-hospital transport along with the appropriat e accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperat ure , IBP , EtCO2 and FiCO2 readings. 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.

Source page: https://510kreport.com/device/K150512
Methodology: https://510kreport.com/methodology