Cleared Traditional

MCDONALD FOLDING FORCEPS (K885230) - FDA 510(k) Clearance

Class I Ophthalmic device.

K885230 · Alcon Laboratories · Ophthalmic device
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May 1989
Decision
148d
Days
Class 1
Risk

K885230 is an FDA 510(k) clearance for the MCDONALD FOLDING FORCEPS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on May 17, 1989 after a review of 148 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 Alcon Laboratories devices

Submission Details

510(k) Number K885230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1988
Decision Date May 17, 1989
Days to Decision 148 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNR Forceps, 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.