# K151512: Star 60

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Private Limited
- Decided: Feb 14, 2016 after 255 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: 9 generations back to K941811 (1994). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series, Welch Allyn, Inc. (2010) Summary page 4.
- K120132: Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor, Philips Medical Systems (2012) Summary page 4.
- K060820: Cycle BP Monitor and Pulse Oximeter, Model 1060, Suntech Medical, Inc. (2006) Summary page 4.
- K103763: Stellar 300, Larsen & Toubro Limited (2011) Summary page 4.

## Indications for use
Star 60 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 along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3L/5L), SpO2, Respiration, Temperature, NIBP, IBP and Capnography (CO2). It can also display the numerical values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, 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/K151512
Methodology: https://510kreport.com/methodology