Cleared Traditional

K023816 - CANON FULL AUTO TONOMETER TX-F

K023816 is an FDA 510(k) clearance for CANON FULL AUTO TONOMETER TX-F, manufactured by Canon, Inc.-Utsunomiya Optical Products Operation. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K023816 · Canon, Inc.-Utsunomiya Optical Products Operation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
11d
Days
Class 2
Risk

K023816 is an FDA 510(k) clearance for the CANON FULL AUTO TONOMETER TX-F. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Canon, Inc.-Utsunomiya Optical Products Operation (Lake Success, US). The FDA issued a Cleared decision on November 26, 2002 after a review of 11 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023816

510(k) Number K023816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date November 26, 2002
Days to Decision 11 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 110d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
KENT DONOHUE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K023816.
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · Reichert, Inc. · Jan 2004
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
APPLANATION TONOMETER
K023676 · Optilasa, S.L. · Apr 2003
KOWA AUTOMATED TONOMETER KT-500
K013805 · Kowa Optimed, Inc. · Oct 2002
TGDC-01 PRA
K021937 · Truevision Instruments · Oct 2002
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
K013259 · Leica Microsystems, Inc. O.I.D. · Feb 2002
K023816 · CANON FULL AUTO TONOMETER TX-F
Download PDF FDA Summary Canon, Inc.-Utsunomiy…