Cleared Traditional

K922242 - 910T MONTORIZED INSTRUMENT TABLE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K922242 · R.H. Burton Co. · Ophthalmic device
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Sep 1992
Decision
140d
Days
Class 1
Risk

K922242 is an FDA 510(k) clearance for the 910T MONTORIZED INSTRUMENT TABLE. Classified as Table, Instrument, Powered, Ophthalmic (product code HRJ), Class I - General Controls.

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on September 30, 1992 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4855 - 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 K922242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date September 30, 1992
Days to Decision 140 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
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRJ Table, Instrument, Powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4855
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.