Cleared Traditional

K820325 - STERICIDAL

K820325 · Breger Mueller West · Ophthalmic device
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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.

FDA 510(k) Submission Details - K820325

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 42
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K820325.
OPTACRY/95 BLUE CONTACT LENS BLANKS
K820815 · Optacryl, Inc. · May 1982
OPTACRY/ 95 GREEN CONTACT LENS BLANKS
K820816 · Optacryl, Inc. · May 1982
OPTACRY/95 GRAY CONTACT LENS BLANKS
K820817 · Optacryl, Inc. · May 1982
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
K820511 · Bausch & Lomb, Inc. · Apr 1982
CONCENTRATED CLEANER FOR HARD CONTACTS
K820818 · Bausch & Lomb, Inc. · Apr 1982
LENS-PAC
K813528 · The Plactory · Jan 1982
K820325 · STERICIDAL
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