Cleared Traditional

K032422 - EUSOL-C

K032422 · Al.Chi.Mi.A · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
132d
Days
-
Risk

K032422 is an FDA 510(k) clearance for the EUSOL-C. Classified as Media, Corneal Storage (product code LYX).

Submitted by Al.Chi.Mi.A (Hasbrouck Heights, US). The FDA issued a Cleared decision on December 15, 2003 after a review of 132 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.

FDA 510(k) Submission Details - K032422

510(k) Number K032422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2003
Decision Date December 15, 2003
Days to Decision 132 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -

Regulatory Peers - LYX Media, Corneal Storage

All 20
Devices cleared under the same product code (LYX) and FDA review panel - the closest regulatory comparables to K032422.
Cornea Cold
K151061 · Eurobio · Aug 2015
LIFE4C
K063304 · Numedis, Inc. · Dec 2007
EUSOL-C
K063617 · Al.Chi.Mi.A · Feb 2007
THE CHEN MEDIUM
K954548 · Chen Ophthalmic Laboratories · May 1996
OPTISOL-GS CORNEAL STORAGE MEDIA
K924165 · Chiron Intraoptics · Oct 1992
DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED
K921728 · Chiron Intraoptics · Jun 1992
K032422 · EUSOL-C
Download PDF FDA Summary Al.Chi.Mi.A