Cleared Traditional

K924785 - BURTON RADIUSGAUGE - MODEL 2030 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K924785 · R.H. Burton Co. · Ophthalmic device
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Apr 1993
Decision
194d
Days
Class 1
Risk

K924785 is an FDA 510(k) clearance for the BURTON RADIUSGAUGE - MODEL 2030. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 5, 1993 after a review of 194 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1425 - 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 R.H. Burton Co. devices

Submission Details

510(k) Number K924785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date April 05, 1993
Days to Decision 194 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
84d slower than avg
Panel avg: 110d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLM Instrument, Measuring, Lens, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1425
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.