Cleared Traditional

ECHO-COMP (K800766) - FDA 510(k) Clearance

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

K800766 · Digisonics, Inc. · Cardiovascular device
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Apr 1980
Decision
17d
Days
Class 2
Risk

K800766 is an FDA 510(k) clearance for the ECHO-COMP. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Digisonics, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Digisonics, Inc. devices

Submission Details

510(k) Number K800766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 24, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 177
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K800766.
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
Q3000
K834567 · Quinton, Inc. · Apr 1984
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979
MODEL 5621A INTERFACE
K780768 · Hewlett-Packard Co. · May 1978
AUTOMATED PHYSIOLOGIC PROFILER
K780530 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978