Cleared Traditional

K841762 - WOODLYN APPLANATION TONOMETER

K841762 is the FDA 510(k) clearance for WOODLYN APPLANATION TONOMETER by Woodlyn, Inc.. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K841762 · Woodlyn, Inc. · Ophthalmic device
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Aug 1984
Decision
97d
Days
Class 2
Risk

K841762 is an FDA 510(k) clearance for the WOODLYN APPLANATION TONOMETER. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - 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 K841762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1984
Decision Date August 02, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
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 - HKX Tonometer, Ac-powered

All 23
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K841762.
KEELER PULSAIR NON CONTACT TONOMETER
K870750 · Keeler Instruments, Inc. · Mar 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · Bio-Rad · Feb 1987
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K863217 · Bio-Rad · Sep 1986
CAT 100
K840836 · CooperVision, Inc. · Jun 1984
CLERZ LUBRICATING/REWETTING SOLUTION
K833494 · CooperVision, Inc. · Jan 1984
AO NON-CONTACT II TONOMETER
K802419 · American Optical Corp. · Nov 1980