Cleared Traditional

K140409 - FLENTS PLASTIC EYE WASH CUP (FDA 510(k) Clearance)

K140409 · Apothecary Products, Inc. · Ophthalmic device
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Jul 2014
Decision
141d
Days
-
Risk

K140409 is an FDA 510(k) clearance for the FLENTS PLASTIC EYE WASH CUP. Classified as Cup, Eye (product code LXQ).

Submitted by Apothecary Products, Inc. (Burnsville, US). The FDA issued a Cleared decision on July 9, 2014 after a review of 141 days - within the typical 510(k) review window.

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: 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.

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Submission Details

510(k) Number K140409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date July 09, 2014
Days to Decision 141 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 110d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXQ Cup, Eye
Device Class -