Cleared Traditional

K060780 - TONOMETER DIATON

K060780 is an FDA 510(k) clearance for TONOMETER DIATON, manufactured by Ryazan State Instruments. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K060780 · Ryazan State Instruments · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
15d
Days
Class 2
Risk

K060780 is an FDA 510(k) clearance for the TONOMETER DIATON. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Ryazan State Instruments (Long Beach, US). The FDA issued a Cleared decision on April 6, 2006 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 - K060780

510(k) Number K060780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date April 06, 2006
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.

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 Consultant

Intertek Testing Services
NEIL E DEVINE

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 - HKX Tonometer, Ac-powered

All 57
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K060780.
NON-CONTACT TONOMETER, MODEL FT-1000
K073087 · Tomey Corporation · Nov 2008
OCULAR RESPONSE ANALYZER
K081756 · Reichert, Inc. · Aug 2008
KOWA KT-800
K053444 · Kowa Co. , Ltd. · Jun 2006
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
K042099 · Retinapharma Technologies, Inc. · Dec 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · Reichert, Inc. · Jan 2004
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
K060780 · TONOMETER DIATON
Download PDF FDA Summary Ryazan State Instrume…