Cleared Traditional

K863387 - MULTIPLE

K863387 is the FDA 510(k) clearance for MULTIPLE by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K863387 · Del Mar Avionics · Cardiovascular device
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Sep 1987
Decision
366d
Days
Class 2
Risk

K863387 is an FDA 510(k) clearance for the MULTIPLE. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Del Mar Avionics devices

Submission Details

510(k) Number K863387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date September 04, 1987
Days to Decision 366 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
241d slower than avg
Panel avg: 125d · This submission: 366d
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 35
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K863387.
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
K873032 · Biosound, Inc. · Feb 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · Hewlett-Packard Co. · Feb 1988
GENESIS II
K871697 · Biosound, Inc. · Nov 1987
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
K871400 · Ge Medical Systems Information Technologies · Jul 1987
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859 · Biosound, Inc. · Feb 1987
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657 · Advanced Technology Laboratories, Inc. · Feb 1987