Cleared Traditional

CANON FULL AUTO TONOMETER TX-F (K023816) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023816 · Canon, Inc.-Utsunomiya Optical Products Operation · Ophthalmic device
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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.

View all Canon, Inc.-Utsunomiya Optical Products Operation devices

Submission Details

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
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.

Device Classification

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
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