# K082685: Galaxy 55

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Sep 26, 2008 after 11 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). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 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.

## Indications for use
The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO 2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO 2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, FtCO2, FiCO 2, N 2 0, 02, 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/K082685
Methodology: https://510kreport.com/methodology