Cleared Traditional

K042560 - STELLAR 404 MONITORING SYSTEM

K042560 is an FDA 510(k) clearance for STELLAR 404 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 15-day FDA review.

K042560 · Larsen & Toubro Limited · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2004
Decision
15d
Days
Class 2
Risk

K042560 is an FDA 510(k) clearance for the STELLAR 404 MONITORING SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Larsen & Toubro Limited (Schaumburg, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 15 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 - K042560

510(k) Number K042560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date October 06, 2004
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
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 K042560.
STAR 50 MONITORING SYSTEM
K051608 · Larsen & Toubro Limited · Jun 2005
PLANET 50 MONITORING SYSTEM
K043370 · Larsen & Toubro Limited · Feb 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
8600 VITAL SIGNS MONITOR
K042569 · Criticare Systems, Inc. · Sep 2004
TRIO MONITOR
K041907 · Datascope Corp. · Jul 2004
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
K041376 · Analogic Corp. · Jul 2004