Cleared Traditional

K843646 - STEINWAY MICRO-KERATO-TREPHINE

K843646 is an FDA 510(k) clearance for STEINWAY MICRO-KERATO-TREPHINE, manufactured by Steinway Instrument Co., Inc.. The device is a Class 1 Ophthalmic device with product code HRH cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K843646 · Steinway Instrument Co., Inc. · Ophthalmic device
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Jan 1985
Decision
108d
Days
Class 1
Risk

K843646 is an FDA 510(k) clearance for the STEINWAY MICRO-KERATO-TREPHINE. Classified as Trephine, Manual, Ophthalmic (product code HRH), Class I - General Controls.

Submitted by Steinway Instrument Co., Inc. (San Diego, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Steinway Instrument Co., Inc. devices

FDA 510(k) Submission Details - K843646

510(k) Number K843646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date January 03, 1985
Days to Decision 108 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 110d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

HRH Device Classification - Class 1, General Controls

Product Code HRH Trephine, Manual, 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 - HRH Trephine, Manual, Ophthalmic

Devices cleared under the same product code (HRH) and FDA review panel - the closest regulatory comparables to K843646.
DEKNATEL (R) TREPHINE
K862524 · Deknatel, Inc. · Aug 1986
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
K861825 · Storz Instrument Co. · Jun 1986
PEARCE CORNEAL TREPHINE
K812723 · Visitec Co. · Oct 1981
CORNEAL CUTTER AND ACCESSORIES
K781411 · Codman & Shurtleff, Inc. · Sep 1978
TROUTMAN CORNEAL PUNCH
K771866 · Edward Weck, Inc. · Nov 1977