Cleared Traditional

K121579 - EK DELIVERY DEVICE

K121579 is an FDA 510(k) clearance for EK DELIVERY DEVICE, manufactured by Tdak Medical, Inc.. The device is a Class 1 Ophthalmic device with product code OTZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

FDA 510(k) Submission Details - K121579

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.

OTZ Device Classification - Class 1, General Controls

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.