Cleared Traditional

K832437 - MEDIC LUX DIAGNOSTIC SETS

K832437 is an FDA 510(k) clearance for MEDIC LUX DIAGNOSTIC SETS, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K832437 · Keeler Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Keeler Instruments, Inc. devices

FDA 510(k) Submission Details - K832437

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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HLJ Ophthalmoscope, Battery-powered

All 27
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K832437.
OPHTHALMOSCOPE
K925757 · Rudolf Riester GmbH & Co. KG · Aug 1993
MIS
K923543 · Ceram Optec, Inc. · Mar 1993
INDIRECT OPHTHALMOSCOPE
K853891 · Carl Zeiss, Inc. · Oct 1985
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215 · Jedmed Instrument Co. · Mar 1983
SOLA COMMIDO LOUPE
K760770 · Codman & Shurtleff, Inc. · Oct 1976
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
K760771 · Codman & Shurtleff, Inc. · Oct 1976