Cleared Abbreviated

K092663 - ELI 350 ELECTROCARDIOGRAPH

K092663 is an FDA 510(k) clearance for ELI 350 ELECTROCARDIOGRAPH, manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K092663 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
105d
Days
Class 2
Risk

K092663 is an FDA 510(k) clearance for the ELI 350 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 14, 2009 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K092663

510(k) Number K092663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2009
Decision Date December 14, 2009
Days to Decision 105 days
Submission Type Abbreviated
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
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

DPS Device Classification - Class 2, Special Controls

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 Peers - DPS Electrocardiograph

All 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K092663.
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K092663 · ELI 350 ELECTROCARDIOGRAPH
Download PDF FDA Summary Mortara Instrument, I…