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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Citech
ERIN SPARNON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKY Tonometer, Manual

All 53
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K032769.
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
TONO-PEN TONOMETER TIP COVER
K033146 · Tra & Accessories · Nov 2004
PASCAL DYNAMIC CONTOUR TONOMETER
K032967 · Smt Swiss Microtechnology AG · Nov 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · Luneau SA · Feb 2003
F 900
K022054 · C.S.O. S.R.L. · Aug 2002
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
K032769 · EYESOPEN TONOMETER
Download PDF FDA Summary Eye-Deas, LLC