Cleared Special

K152644 - KEELER DISPOSABLE TONOMATE

K152644 is the FDA 510(k) clearance for KEELER DISPOSABLE TONOMATE by Keeler Limited. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Special 510(k) pathway after a 106-day FDA review.

K152644 · Keeler Limited · Ophthalmic device
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Dec 2015
Decision
106d
Days
Class 2
Risk

K152644 is an FDA 510(k) clearance for the KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Keeler Limited (Windsor, GB). The FDA issued a Cleared decision on December 31, 2015 after a review of 106 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Keeler Limited devices

Submission Details

510(k) Number K152644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2015
Decision Date December 31, 2015
Days to Decision 106 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - HKY Tonometer, Manual

All 17
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