Cleared Traditional

K830366 - DIAMOND KNIFE

K830366 is an FDA 510(k) clearance for DIAMOND KNIFE, manufactured by Koi, Inc.. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K830366 · Koi, Inc. · Ophthalmic device
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Mar 1983
Decision
33d
Days
Class 1
Risk

K830366 is an FDA 510(k) clearance for the DIAMOND KNIFE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Koi, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 33 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 - K830366

510(k) Number K830366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1983
Decision Date March 09, 1983
Days to Decision 33 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 110d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

HNN Device Classification - Class 1, General Controls

Product Code HNN Knife, 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 - HNN Knife, Ophthalmic

All 23
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K830366.
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · Codman & Shurtleff, Inc. · Dec 1984
MICROSURGICAL KNIFE
K841951 · Ethicon, Inc. · Jun 1984
RUBY KNIVES FOR OPHTH. SURGERY
K832844 · Keeler Instruments, Inc. · Sep 1983
MICROSURGERY KNIFE
K820618 · Visitec Co. · Apr 1982
PILLING K KNIFE
K812918 · Narco Scientific · Nov 1981
TOME'S #'S 1221,1222,1223,1314,6640,6642
K791980 · Edward Weck, Inc. · Oct 1979