Cleared Traditional

HYDROGEL CANALICULAR PLUG (K040912) - FDA 510(k) Clearance

K040912 · Partners IN Biomaterials, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Nov 2004
Decision
222d
Days
-
Risk

K040912 is an FDA 510(k) clearance for the HYDROGEL CANALICULAR PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Partners IN Biomaterials, Inc. (San Dimas, US). The FDA issued a Cleared decision on November 16, 2004 after a review of 222 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. 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.

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Submission Details

510(k) Number K040912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date November 16, 2004
Days to Decision 222 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
112d slower than avg
Panel avg: 110d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -