Cleared Traditional

K843812 - WOODLYN CLASSIC CATARACT ACUITY TEST

K843812 is an FDA 510(k) clearance for WOODLYN CLASSIC CATARACT ACUITY TEST, manufactured by Woodlyn, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K843812 · Woodlyn, Inc. · Ophthalmic device
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Dec 1984
Decision
74d
Days
Class 2
Risk

K843812 is an FDA 510(k) clearance for the WOODLYN CLASSIC CATARACT ACUITY TEST. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 74 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 Woodlyn, Inc. devices

FDA 510(k) Submission Details - K843812

510(k) Number K843812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date December 11, 1984
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-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 - HLI Ophthalmoscope, Ac-powered

All 72
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K843812.
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597 · Nidek, Inc. · Feb 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971 · Nidek, Inc. · Feb 1985
CANON AUTO KERATOMETER K-1
K844054 · Canon USA, Inc. · Dec 1984
BINOCULAR INDIRECT OPHTHALMOSCOPE
K843304 · Mentor O & O, Inc. · Nov 1984
WOODLYN CLASSIC SLIT LAMP HSSL-CL
K841761 · Woodlyn, Inc. · Aug 1984
WOODLYN CLASSIC JAVAL OPHTHALMOMETER
K841764 · Woodlyn, Inc. · Aug 1984