Cleared Traditional

K832050 - MORTARA INSTRUMENT #101

K832050 is an FDA 510(k) clearance for MORTARA INSTRUMENT #101, 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 172-day FDA review.

K832050 · Mortara Instrument, Inc. · Cardiovascular device
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Dec 1983
Decision
172d
Days
Class 2
Risk

K832050 is an FDA 510(k) clearance for the MORTARA INSTRUMENT #101. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Walker, US). The FDA issued a Cleared decision on December 13, 1983 after a review of 172 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 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 - K832050

510(k) Number K832050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1983
Decision Date December 13, 1983
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 K832050.
E 310 ELECTROCARDIOGRAPH
K833951 · Burdick Corp. · May 1984
MINI PECG-MODIFICATION
K841148 · Intersect Systems, Inc. · Apr 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
MINI-PECG
K832883 · Intersect Systems, Inc. · Dec 1983
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983
PACEMAKER EVALUATION MODULE-330
K833470 · Marquette Electronics, Inc. · Nov 1983