Cleared Traditional

K043370 - PLANET 50 MONITORING SYSTEM

K043370 is an FDA 510(k) clearance for PLANET 50 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 69-day FDA review.

K043370 · Larsen & Toubro Limited · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
69d
Days
Class 2
Risk

K043370 is an FDA 510(k) clearance for the PLANET 50 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 February 15, 2005 after a review of 69 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 - K043370

510(k) Number K043370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date February 15, 2005
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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.
NED 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 K043370.
TRIO MONITOR
K051897 · Datascope Corp. · Aug 2005
UNITY NETWORK ID
K051518 · Ge Medical Systems Information Technologies · Jul 2005
STAR 50 MONITORING SYSTEM
K051608 · Larsen & Toubro Limited · Jun 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
STELLAR 404 MONITORING SYSTEM
K042560 · Larsen & Toubro Limited · Oct 2004
8600 VITAL SIGNS MONITOR
K042569 · Criticare Systems, Inc. · Sep 2004