Cleared Traditional

K851702 - MORTARA INSTRUMENT MODEL EL-1

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

K851702 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 191
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
K853213 · Fukuda Denshi USA, Inc. · Oct 1985
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
OXFORD VDT-40 DISPLAY TERMINAL
K852207 · Oxford Medilog, Inc. · Jun 1985