Cleared Traditional

K861748 - RUBY & SAPPHIRE BLADE HOLDER

K861748 is the FDA 510(k) clearance for RUBY & SAPPHIRE BLADE HOLDER by Keeler Instruments, Inc.. It is a Class 1 Ophthalmic device (product code HNN) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K861748 · Keeler Instruments, Inc. · Ophthalmic device
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Jun 1986
Decision
27d
Days
Class 1
Risk

K861748 is an FDA 510(k) clearance for the RUBY & SAPPHIRE BLADE HOLDER. 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 2, 1986 after a review of 27 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 Keeler Instruments, Inc. devices

Submission Details

510(k) Number K861748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date June 02, 1986
Days to Decision 27 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
83d faster than avg
Panel avg: 110d · This submission: 27d
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.

Regulatory Peers - HNN Knife, Ophthalmic

All 17
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K861748.
PRISMA DISPOSABLE MVR/STILETTO BLADE
K874979 · Advanced Surgical Products, Inc. · Apr 1988
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
K864290 · Keeler Instruments, Inc. · Dec 1986
SAPPHIRE KNIFE BLADE
K861744 · Keeler Instruments, Inc. · Jun 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · Storz Instrument Co. · May 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · Storz Instrument Co. · Mar 1986
SMARTKNIFE SYSTEM
K853063 · CooperVision, Inc. · Nov 1985