Cleared Traditional

K990672 - LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET

K990672 · Hurricane Medical · Ophthalmic device
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May 1999
Decision
77d
Days
-
Risk

K990672 is an FDA 510(k) clearance for the LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Hurricane Medical (Bradenton, US). The FDA issued a Cleared decision on May 18, 1999 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K990672

510(k) Number K990672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1999
Decision Date May 18, 1999
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
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 9
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K990672.
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012
MEDPOR COATED TEAR DRAIN
K012108 · Porex Surgical, Inc. · Dec 2001
FCI CRAWFORD PROBE INTUBATION SETS
K991238 · Fci Ophthalmics, Inc. · Jul 1999
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K973633 · Atrion Medical Products, Inc. · Jan 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · Atrion Medical Products, Inc. · Jan 1998
IOLAB LACRIMAL DUCT CATHETER
K935233 · Chiron Vision Corp. · Sep 1994