Cleared Traditional

K874861 - ACUSON S328 TRANSDUCER FOR CARDIAC COLO...

K874861 is an FDA 510(k) clearance for ACUSON S328 TRANSDUCER FOR CARDIAC COLO..., manufactured by Acuson Computed Sonography. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K874861 · Acuson Computed Sonography · Cardiovascular device
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May 1988
Decision
166d
Days
Class 2
Risk

K874861 is an FDA 510(k) clearance for the ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 166 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 Acuson Computed Sonography devices

FDA 510(k) Submission Details - K874861

510(k) Number K874861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1987
Decision Date May 11, 1988
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
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 14
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K874861.
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · Hewlett-Packard Co. · Feb 1990
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · General Electric Co. · Jun 1988
ACCUCOM 2
K874138 · Datascope Corp. · Jun 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
K875266 · Toshiba Medical Systems · Apr 1988
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
K872441 · Advanced Technology Laboratories, Inc. · Feb 1988
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
K860121 · NuMED, Inc. · Jun 1986