Cleared Traditional

K870251 - CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM (FDA 510(k) Clearance)

K870251 · Bioclinical Laboratory Services, Inc. · Ophthalmic device
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Apr 1987
Decision
75d
Days
-
Risk

K870251 is an FDA 510(k) clearance for the CHONDROITIN SULFATE 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 K870251 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 -