Cleared Traditional

K113508 - DACRYOCATH

K113508 · Armadillo Biomedical, LLC · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
277d
Days
-
Risk

K113508 is an FDA 510(k) clearance for the DACRYOCATH. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Armadillo Biomedical, LLC (Irvine, US). The FDA issued a Cleared decision on August 31, 2012 after a review of 277 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 - K113508

510(k) Number K113508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date August 31, 2012
Days to Decision 277 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
167d slower than avg
Panel avg: 110d · This submission: 277d
Pathway characteristics
Predicate-based equivalence.

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

All 29
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K113508.
LACRIFAST
K120886 · Hiroyasu Higuchi · Dec 2012
DCS LACRIMAL STENT
K113316 · Dcs Surgical, Inc. · Nov 2012
LACRICATH LACRIMAL DUCT CATHETER
K113867 · Quest Medical, Inc. · Oct 2012
CRAWFORD BIOCANALICULUS INTUBATION
K121142 · Fci Sas (France Chirurgie Instrumentation) · Aug 2012
MASTERKA 40 MASTERKA 35 MASTERKA 30
K113536 · Fci Sas (France Chirurgie Instrumentation) · Aug 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012
K113508 · DACRYOCATH
Download PDF FDA Summary Armadillo Biomedical,…