Cleared Traditional

K812255 - ETHICON LACRIMAL STENT

K812255 is the FDA 510(k) clearance for ETHICON LACRIMAL STENT by Ethicon, Inc.. It is a Class 1 Ophthalmic device (product code HNL) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K812255 · Ethicon, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
8d
Days
Class 1
Risk

K812255 is an FDA 510(k) clearance for the ETHICON LACRIMAL STENT. Classified as Probe, Lachrymal (product code HNL), Class I - General Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981 after a review of 8 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 Ethicon, Inc. devices

Submission Details

510(k) Number K812255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1981
Decision Date August 20, 1981
Days to Decision 8 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
102d faster than avg
Panel avg: 110d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (HNL) and FDA review panel - the closest regulatory comparables to K812255.
CONCEPT FIBER OPTIC CANALICULUS INTUBA
K843491 · Concept, Inc. · Oct 1984
STERILE OIL AND GUIDEWIRE
K833671 · CooperVision, Inc. · Jan 1984
LACIMAL INTUBATION SETS
K831901 · Visitec Co. · Jul 1983
CONCEPT CANALICULUS INTUBATION SET
K802845 · Concept, Inc. · Dec 1980
JACKSON LACRIMAL INTUBATION SET
K801232 · Storz Instrument Co. · Jun 1980
CRAWFORD LACRIMAL INTUBATION SET
K800089 · Jedmed Instrument Co. · Mar 1980