Cleared Traditional

K946226 - CUSTOM OCULAR PROSTHESIS

K946226 is an FDA 510(k) clearance for CUSTOM OCULAR PROSTHESIS, manufactured by Frank Tanaka, Ocularist, Inc.. The device is a Class 1 Ophthalmic device with product code HQH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K946226 · Frank Tanaka, Ocularist, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K946226

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.

HQH Device Classification - Class 1, General Controls

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.