Cleared Special

K142914 - DacryoCATH

K142914 · Armadillo Biomedical, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Armadillo Biomedical, LLC devices

FDA 510(k) Submission Details - K142914

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.

OKS Device Classification - Class 0,

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.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K142914.
Ritleng®+ and Ritleng®+ PVP
K201892 · Fci (France Chirurgie Instrumentation) Sas · Mar 2021
LacriJet®
K201606 · Fci (France Chirurgie Instrumentation) Sas · Dec 2020
LACRICATH LACRIMAL DUCT CATHETER
K113867 · Quest Medical, Inc. · Oct 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012
MEDPOR COATED TEAR DRAIN
K012108 · Porex Surgical, Inc. · Dec 2001
IOLAB LACRIMAL DUCT CATHETER
K935233 · Chiron Vision Corp. · Sep 1994