Cleared Traditional

K792373 - IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-

K792373 is the FDA 510(k) clearance for IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- by Ipco Corp.. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K792373 · Ipco Corp. · Cardiovascular device
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Feb 1980
Decision
79d
Days
Class 2
Risk

K792373 is an FDA 510(k) clearance for the IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Ipco Corp. (Walker, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ipco Corp. devices

Submission Details

510(k) Number K792373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date February 13, 1980
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 40
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K792373.
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980
ULTRA IMAGER
K800553 · Honeywell, Inc. · Jul 1980
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · Hewlett-Packard Co. · Mar 1978
HIGH-SPEED SECTOR SCANNING SSL-52H
K771292 · Toshiba Medical Systems · Aug 1977
ECHOCARDIOGRAPHY SYS., MODEL 3830
K770755 · Honeywell, Inc. · May 1977