Cleared Traditional

ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (K881369) - FDA 510(k) Clearance

K881369 · Advantage Diagnostics Corp. · Ophthalmic device
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May 1988
Decision
42d
Days
-
Risk

K881369 is an FDA 510(k) clearance for the ADVANCE DIAGNOSTICS DISPOSABLE EYECUP. Classified as Cup, Eye (product code LXQ).

Submitted by Advantage Diagnostics Corp. (Tucson, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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.

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Submission Details

510(k) Number K881369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date May 13, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXQ Cup, Eye
Device Class -