Cleared Traditional

K811117 - EYE CARE TRAY (FDA 510(k) Clearance)

K811117 · American Pharmaseal Div. Ahsc · Ophthalmic device
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Jul 1981
Decision
83d
Days
-
Risk

K811117 is an FDA 510(k) clearance for the EYE CARE TRAY.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 83 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.

View all American Pharmaseal Div. Ahsc devices

Submission Details

510(k) Number K811117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1981
Decision Date July 16, 1981
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -