Cleared Traditional

K841767 - WOODLYN CLASSIC KERATOMETER

K841767 is the FDA 510(k) clearance for WOODLYN CLASSIC KERATOMETER by Woodlyn, Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K841767 · Woodlyn, Inc. · Ophthalmic device
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Aug 1984
Decision
102d
Days
Class 2
Risk

K841767 is an FDA 510(k) clearance for the WOODLYN CLASSIC KERATOMETER. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Woodlyn, Inc. (Walker, 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

Submission Details

510(k) Number K841767 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
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.

Device Classification

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 21
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K841767.
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
ALCON INDIRECT OPHTHALMOSCOPE
K822104 · Alcon Laboratories · Aug 1982
OPHTHALMOSCOPE, BINOCULAR, INDIRECT
K772214 · Varian Assoc., Inc. · Dec 1977
OPHTHALMOSCOPE, MODEL #11100
K770768 · Welch Allyn, Inc. · May 1977