Cleared Special

K142179 - D-KAT Z-YPE

K142179 is an FDA 510(k) clearance for D-KAT Z-YPE, manufactured by Keeler, Ltd.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Special 510(k) pathway after a 40-day FDA review.

K142179 · Keeler, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
40d
Days
Class 2
Risk

K142179 is an FDA 510(k) clearance for the D-KAT Z-YPE. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Keeler, Ltd. (Broomall, US). The FDA issued a Cleared decision on September 17, 2014 after a review of 40 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142179

510(k) Number K142179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2014
Decision Date September 17, 2014
Days to Decision 40 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 110d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

HKY Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K142179.
Falck Medical Multifunction Tonometer, FAT1
K151491 · Falck Medical, Inc. · Jan 2016
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
K152644 · Keeler Limited · Dec 2015
Sensor Medical Single Use Tonometer Prism
K152308 · Sensor Medical Technology, LLC · Oct 2015
ACCUTIP COVER
K132549 · Accutome, Inc. · Apr 2014
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · Keeler Limited · Feb 2014
OCULAR FORCE GAUGE
K132917 · Ocular Therapeutix, Inc. · Dec 2013