Cleared Traditional

K870249 - MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM (FDA 510(k) Clearance)

K870249 · Bioclinical Laboratory Services, Inc. · Ophthalmic device
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Apr 1987
Decision
75d
Days
-
Risk

K870249 is an FDA 510(k) clearance for the MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM. Classified as Media, Corneal Storage (product code LYX).

Submitted by Bioclinical Laboratory Services, Inc. (Clarence, US). The FDA issued a Cleared decision on April 6, 1987 after a review of 75 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 Bioclinical Laboratory Services, Inc. devices

Submission Details

510(k) Number K870249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date April 06, 1987
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 110d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -