Cleared Traditional

K843491 - CONCEPT FIBER OPTIC CANALICULUS INTUBA

K843491 is an FDA 510(k) clearance for CONCEPT FIBER OPTIC CANALICULUS INTUBA, manufactured by Concept, Inc.. The device is a Class 1 Ophthalmic device with product code HNL cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K843491 · Concept, Inc. · Ophthalmic device
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Oct 1984
Decision
29d
Days
Class 1
Risk

K843491 is an FDA 510(k) clearance for the CONCEPT FIBER OPTIC CANALICULUS INTUBA. Classified as Probe, Lachrymal (product code HNL), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. 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.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K843491

510(k) Number K843491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date October 05, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

HNL Device Classification - Class 1, General Controls

Product Code HNL Probe, Lachrymal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNL Probe, Lachrymal

All 8
Devices cleared under the same product code (HNL) and FDA review panel - the closest regulatory comparables to K843491.
STERILE OIL AND GUIDEWIRE
K833671 · CooperVision, Inc. · Jan 1984
LACIMAL INTUBATION SETS
K831901 · Visitec Co. · Jul 1983
PILLING LACRIMAL INTUBATION SYSTEM
K813187 · Narco Scientific · Jan 1982
ETHICON LACRIMAL STENT
K812255 · Ethicon, Inc. · Aug 1981
CONCEPT CANALICULUS INTUBATION SET
K802845 · Concept, Inc. · Dec 1980
JACKSON LACRIMAL INTUBATION SET
K801232 · Storz Instrument Co. · Jun 1980