Cleared Traditional

K892350 - MAGNILINK SYSTEM 402/5 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K892350 · Coburn Optical Ind., Inc. · Ophthalmic device
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May 1989
Decision
51d
Days
Class 1
Risk

K892350 is an FDA 510(k) clearance for the MAGNILINK SYSTEM 402/5. Classified as System, Reading, Television, Closed-circuit (product code HJG), Class I - General Controls.

Submitted by Coburn Optical Ind., Inc. (Tulsa, US). The FDA issued a Cleared decision on May 26, 1989 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coburn Optical Ind., Inc. devices

Submission Details

510(k) Number K892350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date May 26, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 110d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJG System, Reading, Television, Closed-circuit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5820
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.