Cleared Traditional

K873214 - APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300

K873214 is an FDA 510(k) clearance for APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300, manufactured by General Electric Co.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K873214 · General Electric Co. · Cardiovascular device
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Jun 1988
Decision
292d
Days
Class 2
Risk

K873214 is an FDA 510(k) clearance for the APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 292 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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 General Electric Co. devices

FDA 510(k) Submission Details - K873214

510(k) Number K873214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date June 01, 1988
Days to Decision 292 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
167d slower than avg
Panel avg: 125d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 35
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K873214.
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · Hewlett-Packard Co. · Mar 1991
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K896437 · Kontron Instruments, Inc. · Dec 1990
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · Hewlett-Packard Co. · Feb 1990
ACCUCOM 2
K874138 · Datascope Corp. · Jun 1988
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
K874861 · Acuson Computed Sonography · May 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
K875266 · Toshiba Medical Systems · Apr 1988