Cleared Traditional

K113867 - LACRICATH LACRIMAL DUCT CATHETER (FDA 510(k) Clearance)

K113867 · Quest Medical, Inc. · Ophthalmic device
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Oct 2012
Decision
294d
Days
-
Risk

K113867 is an FDA 510(k) clearance for the LACRICATH LACRIMAL DUCT CATHETER. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on October 19, 2012 after a review of 294 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.

View all Quest Medical, Inc. devices

Submission Details

510(k) Number K113867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2011
Decision Date October 19, 2012
Days to Decision 294 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
184d slower than avg
Panel avg: 110d · This submission: 294d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OKS Lacrimal Stents And Intubation Sets
Device Class -
Definition Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosis; Obstruction Or Laceration; And Conditions Requiring Dacryocystorhinostomy (conventional Or Laser); Or Imperforation Of The Nasolacrimal Duct In An Infant.