Cleared Traditional

BARNES-HIND WEEKLY CLEANER (K812135) - FDA 510(k) Clearance

K812135 · Barnes-Hind, Inc. · Ophthalmic device
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Aug 1981
Decision
34d
Days
-
Risk

K812135 is an FDA 510(k) clearance for the BARNES-HIND WEEKLY CLEANER. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Barnes-Hind, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 34 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 K812135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date August 31, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -