Cleared Traditional

K032871 - PLANET MONITORING SYSTEM

K032871 is an FDA 510(k) clearance for PLANET 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.

K032871 · Larsen & Toubro Limited · Cardiovascular device
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Nov 2003
Decision
56d
Days
Class 2
Risk

K032871 is an FDA 510(k) clearance for the PLANET 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 - K032871

510(k) Number K032871 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.
N.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 K032871.
MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · Philips Medical Systems · Dec 2003
STAR (LUNAR SERIES) MONITORING SYSTEM
K032867 · 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
UNITY NETWORK ID
K021454 · General Electric Medical Systems Information Techn · Oct 2002