Cleared Traditional

K800582 - BARNES-HOND HARD CONTACT LENS STOR. CASE

K800582 · Barnes-Hind, Inc. · Ophthalmic device

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Mar 1980

Decision

11d

Days

Risk

K800582 is an FDA 510(k) clearance for the BARNES-HOND HARD CONTACT LENS STOR. CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Barnes-Hind, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 11 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

FDA 510(k) Submission Details - K800582

510(k) Number	K800582 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 1980
Decision Date	March 25, 1980
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

99d faster than avg

Panel avg: 110d · This submission: 11d

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 20

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K800582.

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

VISALENS ALL PURPOSE SOLUTION FOR LENS

K791523 · Pfizer, Inc. · Feb 1980

VISALENS CONCENTRATED CLEANER CONT LENS

K791524 · Pfizer, Inc. · Nov 1979

FDA 510(k) Resources - Ophthalmic

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

Manufacturer of K800582

Barnes-Hind, Inc.

Mchenry, IL · US

Regulatory profile

7 submissions 7 cleared

100% clearance rate · Active in Ophthalmic

About This 510(k) Record

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 . FDA decision: March 25, 1980. Record added to 510k Database: March 2026.

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FDA monthly sync September 21, 2026