Cleared Traditional

K013805 - KOWA AUTOMATED TONOMETER KT-500

K013805 is an FDA 510(k) clearance for KOWA AUTOMATED TONOMETER KT-500, manufactured by Kowa Optimed, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K013805 · Kowa Optimed, Inc. · Ophthalmic device
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Oct 2002
Decision
330d
Days
Class 2
Risk

K013805 is an FDA 510(k) clearance for the KOWA AUTOMATED TONOMETER KT-500. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Kowa Optimed, Inc. (Washington, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K013805

510(k) Number K013805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date October 11, 2002
Days to Decision 330 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 110d · This submission: 330d
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 57
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K013805.
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
APPLANATION TONOMETER
K023676 · Optilasa, S.L. · Apr 2003
CANON FULL AUTO TONOMETER TX-F
K023816 · Canon, Inc.-Utsunomiya Optical Products Operation · Nov 2002
TGDC-01 PRA
K021937 · Truevision Instruments · Oct 2002
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
K013259 · Leica Microsystems, Inc. O.I.D. · Feb 2002
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K010998 · Langham Ophthalmic Technologies · Jun 2001
K013805 · KOWA AUTOMATED TONOMETER KT-500
Download PDF Kowa Optimed, Inc.