Cleared Traditional

K042099 - TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)

K042099 is an FDA 510(k) clearance for TONOPACH ULTRASONIC TONOMETER/PACHYMETE..., manufactured by Retinapharma Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K042099 · Retinapharma Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
128d
Days
Class 2
Risk

K042099 is an FDA 510(k) clearance for the TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH). Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Retinapharma Technologies, Inc. (Rydal, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 128 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K042099

510(k) Number K042099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2004
Decision Date December 10, 2004
Days to Decision 128 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
18d slower than avg
Panel avg: 110d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HKX Tonometer, Ac-powered

All 57
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K042099.
OCULAR RESPONSE ANALYZER
K081756 · Reichert, Inc. · Aug 2008
KOWA KT-800
K053444 · Kowa Co. , Ltd. · Jun 2006
TONOMETER DIATON
K060780 · Ryazan State Instruments · Apr 2006
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · Reichert, Inc. · Jan 2004
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
APPLANATION TONOMETER
K023676 · Optilasa, S.L. · Apr 2003
K042099 · TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
Download PDF FDA Summary Retinapharma Technolo…