Cleared Traditional

K850119 - PHARMASEAL EYE PREP TRAY (FDA 510(k) Clearance)

Class I Ophthalmic device.

K850119 · American Pharmaseal Div. Ahsc · Ophthalmic device
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May 1985
Decision
115d
Days
Class 1
Risk

K850119 is an FDA 510(k) clearance for the PHARMASEAL EYE PREP TRAY. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Glendale, US). The FDA issued a Cleared decision on May 9, 1985 after a review of 115 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 American Pharmaseal Div. Ahsc devices

Submission Details

510(k) Number K850119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date May 09, 1985
Days to Decision 115 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 110d · This submission: 115d
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.