Cleared Traditional

K091513 - SMART ECG SERIES ELECTROCARDIOGRAPH

K091513 is the FDA 510(k) clearance for SMART ECG SERIES ELECTROCARDIOGRAPH by Edan Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K091513 · Edan Instruments, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
63d
Days
Class 2
Risk

K091513 is an FDA 510(k) clearance for the SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-.... Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on July 24, 2009 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number K091513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date July 24, 2009
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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

Tuv Sud America, Inc.

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 - DPS Electrocardiograph

All 247
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K091513.
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K090483 · Philips Medical Systems · Mar 2009
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · Mortara Instrument, Inc. · Dec 2008