Cleared Traditional

K093017 - STELLAR 300

K093017 is an FDA 510(k) clearance for STELLAR 300, 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 212-day FDA review.

K093017 · Larsen & Toubro Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
212d
Days
Class 2
Risk

K093017 is an FDA 510(k) clearance for the STELLAR 300. 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 April 29, 2010 after a review of 212 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Larsen & Toubro Limited devices

FDA 510(k) Submission Details - K093017

510(k) Number K093017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date April 29, 2010
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01097603 Completed Observational Industry-sponsored

Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation

L&T Noninvasive Blood Pressure Module Performance Validation

Condition studied Blood Pressure
Eligibility All sexes · 1 Year+ · Healthy volunteers accepted
Sponsor Larsen & Toubro Limited (industry)
Study completed - no results published. This trial concluded in but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K093017.
MD2000B VITAL SIGN MONITOR, MODEL MD2000B
K100740 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2010
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
K101259 · Taidoc Technology Corporation · Jun 2010
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · Welch Allyn, Inc. · Jun 2010
INTELLIBRIDGE SYSTEM
K093177 · Philips Medical Systems · Dec 2009
SKYLINE 55, MODEL VER 1
K092153 · Larsen & Toubro Limited · Nov 2009
VITAL SIGNS MONITOR, MODEL: MD500B
K082787 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2009