Cleared Traditional

K924054 - PHONOCARDIOGRAPH

K924054 is an FDA 510(k) clearance for PHONOCARDIOGRAPH, manufactured by Echo Ultrasound. The device is a Class 1 Cardiovascular device with product code DQC cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K924054 · Echo Ultrasound · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
163d
Days
Class 1
Risk

K924054 is an FDA 510(k) clearance for the PHONOCARDIOGRAPH. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Echo Ultrasound (Reedsville, US). The FDA issued a Cleared decision on January 22, 1993 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2390 - 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 Echo Ultrasound devices

FDA 510(k) Submission Details - K924054

510(k) Number K924054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date January 22, 1993
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

DQC Device Classification - Class 1, General Controls

Product Code DQC Phonocardiograph
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DQC Phonocardiograph

All 7
Devices cleared under the same product code (DQC) and FDA review panel - the closest regulatory comparables to K924054.
CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH
K950537 · Cardiophonics, Inc. · Mar 1996
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · Acuson Corp. · Dec 1990
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
K811626 · Honeywell, Inc. · Jul 1981
NIC-200 VENTRICULAR FUNCTION ANALYZER
K792466 · Nicolet Biomedical Instruments · Jan 1980
AMPLIFIER, PC-700
K780116 · Burdick Corp. · Feb 1978
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144
K770757 · Honeywell, Inc. · May 1977