Cleared Special

K142914 - DacryoCATH

K142914 · Armadillo Biomedical, LLC · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Specialists, Inc.
Greg Holland

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

All 29
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K142914.
Lacriflow CL
K170247 · Kaneka Pharma America, LLC · Apr 2017
Nunchaku
K161373 · Fci (France Chirurgie Instrumentation) · Nov 2016
Oasis Lacrimal Intubation Set
K160710 · Anodyne · May 2016
STOPLOSS JONES TUBE
K140290 · Ljt Surgical, Ltd. · Dec 2014
SELF-RETAINING BICANALICULUS INTUBATON SET II
K130375 · Fci Sas (France Chirurgie Instrumentation) · Dec 2013
OPHTACATH KIT
K123831 · France Chirurgae Instrumentation · Jul 2013
K142914 · DacryoCATH
Download PDF FDA Summary Armadillo Biomedical,…