Cleared Traditional

K964312 - MENTOR TONO-PEN 3

K964312 is an FDA 510(k) clearance for MENTOR TONO-PEN 3, manufactured by Mentor Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K964312 · Mentor Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
28d
Days
Class 2
Risk

K964312 is an FDA 510(k) clearance for the MENTOR TONO-PEN 3. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Mentor Ophthalmics, Inc. (Norwell, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 28 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 - K964312

510(k) Number K964312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date November 26, 1996
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

Product Code HKY Tonometer, Manual
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 - HKY Tonometer, Manual

All 49
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K964312.
AUTOMATED OPHTHALMICS SOFTIPS
K992998 · Automated Ophthalmics, Inc. · Jan 2000
GOLDMAN MANUAL TONOMETER
K981432 · Golden Vision, Inc. · Jan 1999
BLOOD FLOW ANALYZER
K970887 · Paradigm Medical Industries, Inc. · Jun 1997
PERKINS HAND-HELD APPLANATION TONOMETER
K961512 · Clement Clarke, Inc. · Jul 1996
KOWA HAND-HELD APPLANATION TONOMETER HA-1
K960924 · Kowa Optimed, Inc. · Jun 1996
BOBES TONOMETER
K945446 · Bobes S.A. · Jun 1995
K964312 · MENTOR TONO-PEN 3
Download PDF FDA Summary Mentor Ophthalmics, I…