Cleared Traditional

K874138 - ACCUCOM 2

K874138 is the FDA 510(k) clearance for ACCUCOM 2 by Datascope Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 12
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
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