Cleared Traditional

K841764 - WOODLYN CLASSIC JAVAL OPHTHALMOMETER

K841764 is an FDA 510(k) clearance for WOODLYN CLASSIC JAVAL OPHTHALMOMETER, 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 102-day FDA review.

K841764 · Woodlyn, Inc. · Ophthalmic device
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Aug 1984
Decision
102d
Days
Class 2
Risk

K841764 is an FDA 510(k) clearance for the WOODLYN CLASSIC JAVAL OPHTHALMOMETER. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Woodlyn, Inc. devices

FDA 510(k) Submission Details - K841764

510(k) Number K841764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1984
Decision Date August 07, 1984
Days to Decision 102 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
8d faster than avg
Panel avg: 110d · This submission: 102d
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 K841764.
WOODLYN CLASSIC CATARACT ACUITY TEST
K843812 · Woodlyn, 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 KERATOMETER
K841767 · Woodlyn, Inc. · Aug 1984
WOODLYN SLIT LAMP HSSL-EC
K841763 · Woodlyn, Inc. · Aug 1984
ALCON INDIRECT OPHTHALMOSCOPE
K822104 · Alcon Laboratories · Aug 1982