Cleared Traditional

STEINWAY MICRO-KERATO-TREPHINE (K843646) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

Submission Details

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.

Device Classification

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.