Cleared Traditional

K930444 - MARCO STANDARD KERATOMETERS

K930444 is an FDA 510(k) clearance for MARCO STANDARD KERATOMETERS, manufactured by Marco Ophthalmic, Inc.. The device is a Class 1 Ophthalmic device with product code HJB cleared through the Traditional 510(k) pathway after a 195-day FDA review.

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

FDA 510(k) Submission Details - K930444

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.

HJB Device Classification - Class 1, General Controls

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.