Cleared Traditional

EK DELIVERY DEVICE (K121579) - FDA 510(k) Clearance

Class I Ophthalmic device.

K121579 · Tdak Medical, Inc. · Ophthalmic device
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Oct 2012
Decision
126d
Days
Class 1
Risk

K121579 is an FDA 510(k) clearance for the EK DELIVERY DEVICE. Classified as Graft Insertion Instrument For Endothelial Keratoplasty (product code OTZ), Class I - General Controls.

Submitted by Tdak Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 3, 2012 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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 Tdak Medical, Inc. devices

Submission Details

510(k) Number K121579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2012
Decision Date October 03, 2012
Days to Decision 126 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
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
Definition A Graft Insertion Device For Endothelial Keratoplasty Is A Device Intended To Be Inserted Into The Eye During Surgery To Direct The Insertion Of A Corneal Graft And Be Removed After Insertion Is Completed.
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.