Cleared Traditional

K851702 - MORTARA INSTRUMENT MODEL EL-1

K851702 is an FDA 510(k) clearance for MORTARA INSTRUMENT MODEL EL-1, manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K851702 · Mortara Instrument, Inc. · Cardiovascular device
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Jul 1985
Decision
96d
Days
Class 2
Risk

K851702 is an FDA 510(k) clearance for the MORTARA INSTRUMENT MODEL EL-1. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 - K851702

510(k) Number K851702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1985
Decision Date July 29, 1985
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 285
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K851702.
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
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MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · Hewlett-Packard Co. · Sep 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · Nihon Kohden America, Inc. · Jul 1985
MEDILOG M3
K852883 · Oxford Medilog, Inc. · Jul 1985
MEDILOG M1
K852884 · Oxford Medilog, Inc. · Jul 1985
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K852207 · Oxford Medilog, Inc. · Jun 1985