Cleared Traditional

K930840 - POST-MYDS(TM) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K930840 · Aukland Medical Plastics, Inc. · Ophthalmic device
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Mar 1994
Decision
377d
Days
Class 1
Risk

K930840 is an FDA 510(k) clearance for the POST-MYDS(TM). Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Aukland Medical Plastics, Inc. (Cary, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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. Elevated predicate reliance profile. 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 Aukland Medical Plastics, Inc. devices

Submission Details

510(k) Number K930840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date March 01, 1994
Days to Decision 377 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
267d slower than avg
Panel avg: 110d · This submission: 377d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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.