Cleared Traditional

K874138 - ACCUCOM 2

K874138 is an FDA 510(k) clearance for ACCUCOM 2, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K874138 · Datascope Corp. · Cardiovascular device
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Jun 1988
Decision
232d
Days
Class 2
Risk

K874138 is an FDA 510(k) clearance for the ACCUCOM 2. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 232 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 Datascope Corp. devices

FDA 510(k) Submission Details - K874138

510(k) Number K874138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date June 01, 1988
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
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 28
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K874138.
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
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · General Electric Co. · 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
BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL
K873673 · Sonicaid, Inc. · Feb 1988