Cleared Traditional

K810403 - KEELER/KONAN SPECULAR MICROSCOPE

K810403 is the FDA 510(k) clearance for KEELER/KONAN SPECULAR MICROSCOPE by Keeler Optical Products , Ltd.. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K810403 · Keeler Optical Products , Ltd. · Ophthalmic device
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May 1981
Decision
84d
Days
Class 2
Risk

K810403 is an FDA 510(k) clearance for the KEELER/KONAN SPECULAR MICROSCOPE. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Keeler Optical Products , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1981 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Keeler Optical Products , Ltd. devices

Submission Details

510(k) Number K810403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date May 13, 1981
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.