Cleared Abbreviated

K093445 - KEELER APPLANATION TONOMETER

Also marketed or referenced as:
T-TYPE KAT, K-TYPE KAT, (KAT)

K093445 is an FDA 510(k) clearance for KEELER APPLANATION TONOMETER, manufactured by Keeler, Ltd.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K093445 · Keeler, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
90d
Days
Class 2
Risk

K093445 is an FDA 510(k) clearance for the KEELER APPLANATION TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Keeler, Ltd. (Broomall, US). The FDA issued a Cleared decision on January 19, 2010 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K093445

510(k) Number K093445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2009
Decision Date January 19, 2010
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
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
Standards-based clearance path.

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 K093445.
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
FALCK APPLANATION TONOMETER (FAT2)
K071755 · Falck Medical, Inc. · Jun 2008
ICARE TONOMETER TA01I
K063873 · Tiolat OY · May 2007
MODIFICATION TO: OCU-FILM TIP COVER
K070534 · Reichert, Inc. · Mar 2007