Cleared Traditional

K032769 - EYESOPEN TONOMETER

K032769 is an FDA 510(k) clearance for EYESOPEN TONOMETER, manufactured by Eye-Deas, LLC. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K032769 · Eye-Deas, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
15d
Days
Class 2
Risk

K032769 is an FDA 510(k) clearance for the EYESOPEN TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Eye-Deas, LLC (Rochester, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 15 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 Eye-Deas, LLC devices

FDA 510(k) Submission Details - K032769

510(k) Number K032769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date September 23, 2003
Days to Decision 15 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
95d faster than avg
Panel avg: 110d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 33
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K032769.
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · Keeler Limited · Feb 2014
OCULAR FORCE GAUGE
K132917 · Ocular Therapeutix, Inc. · Dec 2013
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
C.S.O. TONOMETER
K992835 · Cso · Jun 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K991840 · Bernard B. Fresco · Mar 2000