Cleared Traditional

K040912 - HYDROGEL CANALICULAR PLUG

K040912 · Partners IN Biomaterials, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K040912

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 110d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 48
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K040912.
SNUG PLUG PUNCTUM PLUG
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EAGLEVISION GELLANSERTS, MODEL REF 0040
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DELTA PUNCTUM PLUG
K050851 · Delta Life Science, Inc. · Aug 2005
INTELIPORT OCCLUDING DEVICE
K040231 · Alcon, Inc. · Jul 2004
OPAQUE HERRICK LACRIMAL PLUG
K030300 · Lacrimedics, Inc. · May 2003
SMART PLUG, MODEL 500
K022043 · Medennium, Inc. · Oct 2002
K040912 · HYDROGEL CANALICULAR PLUG
Download PDF FDA Summary Partners IN Biomateri…