Cleared Traditional

K914381 - HORIZON 9000/HIS OPTION AMPLIFIER

K914381 is an FDA 510(k) clearance for HORIZON 9000/HIS OPTION AMPLIFIER, manufactured by Mennen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRR cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K914381 · Mennen Medical, Inc. · Cardiovascular device
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Jan 1992
Decision
117d
Days
Class 2
Risk

K914381 is an FDA 510(k) clearance for the HORIZON 9000/HIS OPTION AMPLIFIER. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2050 - 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 Mennen Medical, Inc. devices

FDA 510(k) Submission Details - K914381

510(k) Number K914381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1991
Decision Date January 28, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRR Device Classification - Class 2, Special Controls

Product Code DRR Amplifier And Signal Conditioner, Biopotential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2050
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 - DRR Amplifier And Signal Conditioner, Biopotential

All 12
Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K914381.
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BARD BIOPOTENTIAL AMPLIFIER
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K813123 · Codman & Shurtleff, Inc. · Nov 1981
HP MODEL 8880A FILTER
K802686 · Hewlett-Packard Co. · Nov 1980
MODEL 15055A MAINFRAME
K791964 · Hewlett-Packard Co. · Oct 1979