Cleared Traditional

K864580 - MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)

K864580 is an FDA 510(k) clearance for MODEL EL-1 W/ST MONITOR OPTION (ACRONYM..., manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K864580

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.

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 368
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K864580.
EK10 ELECTROCARDIOGRAPH
K870880 · Burdick Corp. · Apr 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · Mennen Medical, Inc. · Mar 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