Cleared Traditional

K812010 - KOI LACRIMAL INTUBATION SYSTEM

K812010 is an FDA 510(k) clearance for KOI LACRIMAL INTUBATION SYSTEM, manufactured by Koi, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K812010 · Koi, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
11d
Days
Class 1
Risk

K812010 is an FDA 510(k) clearance for the KOI LACRIMAL INTUBATION SYSTEM. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Koi, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 11 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 Koi, Inc. devices

FDA 510(k) Submission Details - K812010

510(k) Number K812010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date July 28, 1981
Days to Decision 11 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 110d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
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 - HMX Cannula, Ophthalmic

All 49
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K812010.
SITE ANTERIOR CAPSULOTOMER
K843039 · Chiron Vision Corp. · Nov 1984
INFUSION CANNULA
K831192 · Medical Instrument Development Laboratories, Inc. · Jun 1983
OMS INFUSION CANNULA ASSEMBLE
K813481 · Optical Micro Systems, Inc. · Jan 1982
ANIS GUIDING CANNULA
K811455 · American V. Mueller · Jun 1981
CANNULA'S CAT #'S 6636, 6624, 6625
K791982 · Edward Weck, Inc. · Oct 1979
NEEDLES, CANNULAS, CYSTOTOMES
K782169 · Visitec Co. · Feb 1979