Cleared Traditional

K832437 - MEDIC LUX DIAGNOSTIC SETS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832437 · Keeler Instruments, Inc. · Ophthalmic device
Aug 1983
Decision
22d
Days
Class 2
Risk

K832437 is an FDA 510(k) clearance for the MEDIC LUX DIAGNOSTIC SETS. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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.

Submission Details

510(k) Number K832437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date August 16, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 156d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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.