Cleared Abbreviated

K102206 - ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10

K102206 is the FDA 510(k) clearance for ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Abbreviated 510(k) pathway after a 197-day FDA review.

K102206 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
197d
Days
Class 2
Risk

K102206 is an FDA 510(k) clearance for the ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 197 days - an extended review cycle.

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.

View all Mortara Instrument, Inc. devices

Submission Details

510(k) Number K102206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2010
Decision Date February 18, 2011
Days to Decision 197 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
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Standards-based clearance path.

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 Peers - DPS Electrocardiograph

All 220
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K102206.
ELECTROCARDIOGRAPH
K120188 · Edan Instruments, Inc. · Mar 2012
ACG-8511 PORTABLE ECG MONITOR
K110328 · Andon Health Co, Ltd. · Jul 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · Taidoc Technology Corporation · Mar 2011
PC ECG
K102854 · Edan Instruments, Inc. · Dec 2010
ELECTROCARDIOGRAPH
K102830 · Edan Instruments, Inc. · Dec 2010
ELI 250 ELECTROCARDIOGRAPH
K101403 · Mortara Instrument, Inc. · Jul 2010