Cleared Traditional

K812135 - BARNES-HIND WEEKLY CLEANER

K812135 · Barnes-Hind, Inc. · Ophthalmic device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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	-

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 17

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K812135.

BAUSCH & LOMB STERILE ALL PURPOSE SOLU

K820511 · Bausch & Lomb, Inc. · Apr 1982

CONCENTRATED CLEANER FOR HARD CONTACTS

K820818 · Bausch & Lomb, Inc. · Apr 1982

LENSINE EXTRA STRENGTH CLEANER

K812433 · CooperVision, Inc. · Sep 1981

CONTACT LENS CLEANER

K812172 · Alcon Laboratories · Aug 1981

DURALITE LENS

K800192 · American Optical Corp. · Mar 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812135

Barnes-Hind, Inc.

Mchenry, IL · US

Regulatory profile

7 submissions 7 cleared

100% clearance rate · Active in Ophthalmic

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active