STAR (Lunar Series) Monitoring System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K032867 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Skyline 55

  Class II

  FDA 510(k) K081552 Active Cleared 31 Jul 2008

• Star 50 N

  Class II

  FDA 510(k) K103686 Active Cleared 15 Mar 2011

• Planet 55, Model 100

  Class II

  FDA 510(k) K090443 Active Cleared 5 Jun 2009

• Star 55

  Class II

  FDA 510(k) K080173 Active Cleared 8 Feb 2008

• Planet 55

  Class II

  FDA 510(k) K071472 Active Cleared 21 Sep 2007

• Stellar 404 Monitoring System

  Class II

  FDA 510(k) K042560 Active Cleared 6 Oct 2004

See all devices from Larsen & Toubro Limited →

• What is the STAR (Lunar Series) Monitoring System intended for?

  The STAR (Lunar Series) Monitoring System is intended to monitor a single adult, pediatric, or neonatal patient's vital signs at the bedside or during intra-hospital transport, as it is a multiparameter patient monitoring system designed for use with appropriate accessories supplied with the unit.

• How is the STAR (Lunar Series) Monitoring System supplied and what does it include?

  The device is supplied by Larsen & Toubro Limited and is designed for use with appropriate accessories that are supplied with the unit, ensuring it functions as a complete multiparameter patient monitoring system.

• What regulatory pathway was used for the STAR (Lunar Series) Monitoring System and what is its classification?

  The STAR (Lunar Series) Monitoring System was cleared through the FDA's Traditional 510(k) pathway under K032867 and is classified as a Class 2 cardiovascular device under product code MWI, reviewed by the Cardiovascular advisory committee.