Cleared Traditional

K963079 - CANON TX-10 TONOMETER

K963079 is an FDA 510(k) clearance for CANON TX-10 TONOMETER, manufactured by Canon USA, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K963079 · Canon USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
208d
Days
Class 2
Risk

K963079 is an FDA 510(k) clearance for the CANON TX-10 TONOMETER. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Canon USA, Inc. devices

FDA 510(k) Submission Details - K963079

510(k) Number K963079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date March 03, 1997
Days to Decision 208 days
Submission Type Traditional
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
98d slower than avg
Panel avg: 110d · This submission: 208d
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 35
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K963079.
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000
LEICA AT550
K990869 · Leica Microsystems, Inc. · Jun 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · Keeler Instruments, Inc. · Mar 1999
NON-CONTACT TONOMETER T-2
K943939 · Canon, Inc. · May 1995
TIP & MEMBRANE ASSEMBLY
K921443 · Bio-Rad · Jun 1993
BURTON APPLANATION TONOMETER - MODEL T850 & T1000
K924777 · R.H. Burton Co. · Apr 1993