Cleared Traditional

CORNEA PERSERVATION UNIT (K821170) - FDA 510(k) Clearance

K821170 · Xytex Corp. · Ophthalmic device
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Jul 1982
Decision
79d
Days
-
Risk

K821170 is an FDA 510(k) clearance for the CORNEA PERSERVATION UNIT. Classified as Media, Corneal Storage (product code LYX).

Submitted by Xytex Corp. (Walker, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 79 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 Xytex Corp. devices

Submission Details

510(k) Number K821170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1982
Decision Date July 14, 1982
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -