Cleared Traditional

STERICIDAL (K820325) - FDA 510(k) Clearance

K820325 · Breger Mueller West · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
72d
Days
-
Risk

K820325 is an FDA 510(k) clearance for the STERICIDAL. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Breger Mueller West (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982 after a review of 72 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 Breger Mueller West devices

Submission Details

510(k) Number K820325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1982
Decision Date April 21, 1982
Days to Decision 72 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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