Cleared Traditional

K832844 - RUBY KNIVES FOR OPHTH. SURGERY (FDA 510(k) Clearance)

Class I Ophthalmic device.

K832844 · Keeler Instruments, Inc. · Ophthalmic device
Sep 1983
Decision
38d
Days
Class 1
Risk

K832844 is an FDA 510(k) clearance for the RUBY KNIVES FOR OPHTH. SURGERY. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 38 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 K832844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1983
Decision Date September 29, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 156d · This submission: 38d
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.