Cleared Traditional

K791901 - BARNES-HIND WETTING & SOAKING SOLUTION

K791901 is the FDA 510(k) clearance for BARNES-HIND WETTING & SOAKING SOLUTION by Barnes-Hind, Inc.. It is a Class 1 Ophthalmic device (product code HQG) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K791901 · Barnes-Hind, Inc. · Ophthalmic device
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Nov 1979
Decision
52d
Days
Class 1
Risk

K791901 is an FDA 510(k) clearance for the BARNES-HIND WETTING & SOAKING SOLUTION. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Barnes-Hind, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - the FDA ophthalmic device framework. 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 K791901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date November 16, 1979
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 110d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQG Lens, Spectacle, Non-custom (prescription)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HQG Lens, Spectacle, Non-custom (prescription)

All 7
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K791901.
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · American Optical Corp. · Sep 1981
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · Chiron Vision Corp. · Dec 1980
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · American Optical Corp. · Oct 1979
FUL-VUE ASPHERIC CATARACT LENS
K790251 · American Optical Corp. · Feb 1979
AD7 PLASTIC MULTIFOCAL EYEGLASS LENS
K761163 · American Optical Corp. · Dec 1976