Cleared Traditional

K961512 - PERKINS HAND-HELD APPLANATION TONOMETER

K961512 is the FDA 510(k) clearance for PERKINS HAND-HELD APPLANATION TONOMETER by Clement Clarke, Inc.. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961512 · Clement Clarke, Inc. · Ophthalmic device
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Jul 1996
Decision
90d
Days
Class 2
Risk

K961512 is an FDA 510(k) clearance for the PERKINS HAND-HELD APPLANATION TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on July 18, 1996 after a review of 90 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 Clement Clarke, Inc. devices

Submission Details

510(k) Number K961512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1996
Decision Date July 18, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKY Tonometer, Manual
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.