Cleared Traditional

K861744 - SAPPHIRE KNIFE BLADE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K861744 · Keeler Instruments, Inc. · Ophthalmic device
Jun 1986
Decision
34d
Days
Class 1
Risk

K861744 is an FDA 510(k) clearance for the SAPPHIRE KNIFE BLADE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 34 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.

Submission Details

510(k) Number K861744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date June 09, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 156d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.