Cleared Traditional

K963079 - CANON TX-10 TONOMETER

K963079 is the FDA 510(k) clearance for CANON TX-10 TONOMETER by Canon USA, Inc.. It is a Class 2 Ophthalmic device (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

Submission Details

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.

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 22
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K963079.
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000
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
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K921617 · Bio-Rad · Aug 1992