Cleared Traditional

K885349 - SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.

K885349 is an FDA 510(k) clearance for SONOMICROMETER, manufactured by Sonotek Corp.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K885349 · Sonotek Corp. · Cardiovascular device
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Jun 1989
Decision
176d
Days
Class 2
Risk

K885349 is an FDA 510(k) clearance for the SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Sonotek Corp. (San Diego, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 176 days - an extended review 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: 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 Sonotek Corp. devices

FDA 510(k) Submission Details - K885349

510(k) Number K885349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date June 22, 1989
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K885349.
ULTRAMARK 7 ULTRASOUND SYSTEM
K896543 · Advanced Technology Laboratories, Inc. · Feb 1990
GENESIS III, (MOD. 7003/7004)
K894370 · Biosound, Inc. · Jan 1990
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888 · Advanced Biosearch Assn. · Dec 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · Ge Medical Systems Information Technologies · Apr 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878 · Hitachi Medical Corp. of America · Apr 1988