Cleared Traditional

K864580 - MODEL EL-1 W/ST MONITOR OPTION (ACRONYM...

K864580 is the FDA 510(k) clearance for MODEL EL-1 W/ST MONITOR OPTION (ACRONYM... by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K864580 · Mortara Instrument, Inc. · Cardiovascular device
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Feb 1987
Decision
92d
Days
Class 2
Risk

K864580 is an FDA 510(k) clearance for the MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM). 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 20, 1987 after a review of 92 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 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 Mortara Instrument, Inc. devices

Submission Details

510(k) Number K864580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1986
Decision Date February 20, 1987
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K864580.
MODEL 2240 SLAVE SCOPE
K873346 · Marquette Electronics, Inc. · Oct 1987
Q5000 STRESS TEST MONITOR
K864504 · Quinton, Inc. · Apr 1987
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · Hewlett-Packard Co. · Mar 1987
Q700 ELECTROCARDIOGRAPH
K864700 · Quinton, Inc. · Feb 1987
ELECTROCARDIOGRAPH
K865031 · Nihon Kohden America, Inc. · Feb 1987
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
K863100 · Honeywell, Inc. · Feb 1987