Cleared Traditional

K871239 - ACUSON PHYSIOLOGICAL CONTROL MODULE

K871239 is an FDA 510(k) clearance for ACUSON PHYSIOLOGICAL CONTROL MODULE, manufactured by Acuson Computed Sonography. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K871239 · Acuson Computed Sonography · Cardiovascular device
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Jun 1987
Decision
70d
Days
Class 2
Risk

K871239 is an FDA 510(k) clearance for the ACUSON PHYSIOLOGICAL CONTROL MODULE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acuson Computed Sonography devices

FDA 510(k) Submission Details - K871239

510(k) Number K871239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1987
Decision Date June 05, 1987
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K871239.
FITNESS RECUMBENT ERGOMETER, MODEL FT1400
K872548 · Invacare Corp. · Dec 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
MODEL 2240 SLAVE SCOPE
K873346 · Marquette Electronics, Inc. · Oct 1987
Q5000 STRESS TEST MONITOR
K864504 · Quinton, Inc. · Apr 1987
EK10 ELECTROCARDIOGRAPH
K870880 · Burdick Corp. · Apr 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · Mennen Medical, Inc. · Mar 1987