# K172147: STAR 65

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Pvt, Ltd.
- Decided: May 25, 2018 after 312 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: 37 generations back to K941811 (1994). 288 ancestors in all.
No later device cites it as a predicate yet.
1 of 289 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150512: STAR 90, Skanray Technologies Pvt, Ltd. (2015) Summary page 5.
- K161531: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800, Philips Medizin Systeme Boeblingen GmbH (2016) Summary page 5.
- K080173: STAR 55, Larsen & Toubro Limited (2008) Summary page 5.

## Indications for use
Star 65 multi-parameter 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 with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic, Diastolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA 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. It shall be used only by trained clinicians. In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).

Source page: https://510kreport.com/device/K172147
Methodology: https://510kreport.com/methodology