Cleared Traditional

MARCO STANDARD KERATOMETERS (K930444) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930444 · Marco Ophthalmic, Inc. · Ophthalmic device
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Aug 1993
Decision
195d
Days
Class 1
Risk

K930444 is an FDA 510(k) clearance for the MARCO STANDARD KERATOMETERS. Classified as Instrument, Measuring, Corneal Radius (product code HJB), Class I - General Controls.

Submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 195 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1450 - 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 Marco Ophthalmic, Inc. devices

Submission Details

510(k) Number K930444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date August 09, 1993
Days to Decision 195 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 110d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJB Instrument, Measuring, Corneal Radius
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1450
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.