Cleared Traditional

K032867 - STAR (LUNAR SERIES) MONITORING SYSTEM

K032867 is an FDA 510(k) clearance for STAR (LUNAR SERIES) MONITORING SYSTEM, manufactured by Larsen & Toubro Limited. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K032867 · Larsen & Toubro Limited · Cardiovascular device
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Nov 2003
Decision
56d
Days
Class 2
Risk

K032867 is an FDA 510(k) clearance for the STAR (LUNAR SERIES) MONITORING SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Larsen & Toubro Limited (Crofton, US). The FDA issued a Cleared decision on November 10, 2003 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Larsen & Toubro Limited devices

FDA 510(k) Submission Details - K032867

510(k) Number K032867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2003
Decision Date November 10, 2003
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Entela, Inc.
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 174
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K032867.
TRIO MONITOR MODEL 0998-00-0600
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MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
M2376A PHILIPS DEVICE LINK SYSTEM
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PLANET MONITORING SYSTEM
K032871 · Larsen & Toubro Limited · Nov 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · Nihon Kohden America, Inc. · Sep 2003
M2376A DEVICELINK SYSTEM
K030731 · Philips Medical Systems, Inc. · Mar 2003