Cleared Traditional

K897151 - ACUSON V328 AND C5432 TRANSDUCERS (FDA 510(k) Clearance)

Class I Microbiology device.

K897151 · Acuson Corp. · Microbiology device
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Jul 1990
Decision
189d
Days
Class 1
Risk

K897151 is an FDA 510(k) clearance for the ACUSON V328 AND C5432 TRANSDUCERS. Classified as Transport Systems, Anaerobic (product code JTX), Class I - General Controls.

Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 189 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acuson Corp. devices

Submission Details

510(k) Number K897151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date July 03, 1990
Days to Decision 189 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTX Transport Systems, Anaerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.