Not Cleared Post-NSE

DEN200063 - Kerasave (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN200063 · Al.Chi.Mi.A. S.R.L · Ophthalmic device
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May 2022
Decision
578d
Days
Class 2
Risk

DEN200063 is an FDA 510(k) submission (not cleared) for the Kerasave. Classified as Corneal Storage Media With Preservatives Including Anti-fungal (product code QCW), Class II - Special Controls.

Submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicolò, IT). The FDA issued a Not Cleared (DENG) decision on May 2, 2022 after a review of 578 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4320 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 578 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN200063 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 01, 2020
Decision Date May 02, 2022
Days to Decision 578 days
Submission Type Post-NSE
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
468d slower than avg
Panel avg: 110d · This submission: 578d
Pathway characteristics

Device Classification

Product Code QCW Corneal Storage Media With Preservatives Including Anti-fungal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4320
Definition Media To Preserve Human Corneas While In Storage.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.