Cleared Traditional

K914896 - FRIEDMANN ANALYSER 3 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K914896 · Clement Clarke, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
84d
Days
Class 1
Risk

K914896 is an FDA 510(k) clearance for the FRIEDMANN ANALYSER 3. Classified as Screen, Tangent, Projection, Ac-powered (product code HOK), Class I - General Controls.

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on January 23, 1992 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1810 - the FDA ophthalmic device 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 Clement Clarke, Inc. devices

Submission Details

510(k) Number K914896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1991
Decision Date January 23, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOK Screen, Tangent, Projection, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.