Cleared Traditional

BARNES-HIND ROSE BENGAL OPHTHALMIC STR. (K810285) - FDA 510(k) Clearance

K810285 · Barnes-Hind, Inc. · Ophthalmic device
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Apr 1981
Decision
74d
Days
-
Risk

K810285 is an FDA 510(k) clearance for the BARNES-HIND ROSE BENGAL OPHTHALMIC STR..

Submitted by Barnes-Hind, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 74 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 Barnes-Hind, Inc. devices

Submission Details

510(k) Number K810285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1981
Decision Date April 17, 1981
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYC
Device Class -