Cleared Traditional

K851790 - 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY ...

K851790 is an FDA 510(k) clearance for 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY ..., manufactured by Artiberia. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K851790 · Artiberia · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
28d
Days
Class 1
Risk

K851790 is an FDA 510(k) clearance for the 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 28 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 Artiberia devices

FDA 510(k) Submission Details - K851790

510(k) Number K851790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date May 23, 1985
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
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 21
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K851790.
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · Storz Instrument Co. · Mar 1986
SMARTKNIFE SYSTEM
K853063 · CooperVision, Inc. · Nov 1985
STORZ DIAMOND KNIFE
K853403 · Storz Instrument Co. · Nov 1985
CATARACT TRAY
K842647 · Deroyal Industries, Inc. · May 1985
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · Codman & Shurtleff, Inc. · Dec 1984
MICROSURGICAL KNIFE
K841951 · Ethicon, Inc. · Jun 1984