Cleared Traditional

CUSTOM OCULAR PROSTHESIS (K946226) - FDA 510(k) Clearance

Class I Ophthalmic device.

K946226 · Frank Tanaka, Ocularist, Inc. · Ophthalmic device
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Mar 1995
Decision
90d
Days
Class 1
Risk

K946226 is an FDA 510(k) clearance for the CUSTOM OCULAR PROSTHESIS. Classified as Eye, Artificial, Non-custom (product code HQH), Class I - General Controls.

Submitted by Frank Tanaka, Ocularist, Inc. (Tampa, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Frank Tanaka, Ocularist, Inc. devices

Submission Details

510(k) Number K946226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date March 22, 1995
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQH Eye, Artificial, Non-custom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.3200
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.