Cleared Traditional

K832844 - RUBY KNIVES FOR OPHTH. SURGERY

K832844 is an FDA 510(k) clearance for RUBY KNIVES FOR OPHTH. SURGERY, manufactured by Keeler Instruments, Inc.. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K832844 · Keeler Instruments, Inc. · Ophthalmic device
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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.

FDA 510(k) Submission Details - K832844

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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
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 45
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K832844.
MICROSURGICAL KNIFE
K841951 · Ethicon, Inc. · Jun 1984
CORNEAL SCLERAL LANCE
K840855 · Sharpoint, Inc. · May 1984
SURGICAL KNIFE
K834546 · Fine-Cut Diamond Instruments · Mar 1984
LEADING EDGE OPHTHALMIC KNIFE
K831975 · Surgidev Corp. · Aug 1983
MICROSURGICAL KNIFE
K831266 · Vxtra Corp. · Jun 1983
DIAMOND KNIFE
K830366 · Koi, Inc. · Mar 1983
K832844 · RUBY KNIVES FOR OPHTH. SURGERY
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