# K080173: STAR 55

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Feb 8, 2008 after 15 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: 11 generations back to K941811 (1994). 80 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051608: Star 50 Monitoring System, Larsen & Toubro Limited (2005) Summary page 2.
- K053234: PM-9000 Express Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K103686: STAR 50 N (2011), 1 descendant of its own
- K172147: STAR 65 (2018), 0 descendants of its own
- K132033: BM3/BM3 Plus (2013), 0 descendants of its own
- K090172: Star 55 Model 100 (2009), 0 descendants of its own
- K082685: Galaxy 55 (2008), 0 descendants of its own

## Indications for use
The STAR 55 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 (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, 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.

Source page: https://510kreport.com/device/K080173
Methodology: https://510kreport.com/methodology