# K032867: Star (Lunar Series) Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Nov 10, 2003 after 56 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: 1 generation back to K952474 (1995). 2 ancestors in all.
260 later devices descend from it; 1 cites it directly.
1 of 263 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952474: Eagle 3000 Patient Monitor, Marquette Electronics, Inc. (1995) Summary page 2.
- K001020: 8100 Vital Signs Monitor, Criticare Systems, Inc. (2000) Summary page 4.

## Most influential descendants
- K051608: Star 50 Monitoring System (2005), 259 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own

## Indications for use
The STAR (LUNAR SERIES) multiparameter 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 (Lead I / I1 / III / V / AVL / AVF / AVR), Plethysmograph, Respiration and Invasive Blood pressure ( B P I & IBP2). It can also display the digital values of HR/PR, SpOz, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable 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/K032867
Methodology: https://510kreport.com/methodology