Cleared Traditional

K940415 - HORIZON 9000 WS (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940415 · Mennen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
343d
Days
Class 2
Risk

K940415 is an FDA 510(k) clearance for the HORIZON 9000 WS. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on January 6, 1995 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K940415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1994
Decision Date January 06, 1995
Days to Decision 343 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 125d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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.