Cleared Traditional

K841762 - WOODLYN APPLANATION TONOMETER

K841762 is an FDA 510(k) clearance for WOODLYN APPLANATION TONOMETER, manufactured by Woodlyn, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K841762

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
Combination Product No
PCCP Authorized No
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.

HKX Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K841762.
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · Bio-Rad · Feb 1987
SURGICAL IOP MONITOR
K863235 · Ameritek, Inc. · Sep 1986
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