Cleared Special

K142914 - DacryoCATH (FDA 510(k) Clearance)

K142914 · Armadillo Biomedical, LLC · Ophthalmic device
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Jan 2015
Decision
97d
Days
-
Risk

K142914 is an FDA 510(k) clearance for the DacryoCATH. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Armadillo Biomedical, LLC (Encino, US). The FDA issued a Cleared decision on January 12, 2015 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K142914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2014
Decision Date January 12, 2015
Days to Decision 97 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

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.