Cleared Traditional

IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- (K792373) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 77
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K792373.
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