Cleared Traditional

Dynarex Eye Cups (K151575) - FDA 510(k) Clearance

K151575 · Dynarex Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
82d
Days
-
Risk

K151575 is an FDA 510(k) clearance for the Dynarex Eye Cups. Classified as Cup, Eye (product code LXQ).

Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on September 1, 2015 after a review of 82 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 Dynarex Corporation devices

Submission Details

510(k) Number K151575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2015
Decision Date September 01, 2015
Days to Decision 82 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
28d faster than avg
Panel avg: 110d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXQ Cup, Eye
Device Class -