Cleared Traditional

K090326 - RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS

K090326 is an FDA 510(k) clearance for RET CAM II, manufactured by Clarity Medical Systems. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K090326 · Clarity Medical Systems · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
289d
Days
Class 2
Risk

K090326 is an FDA 510(k) clearance for the RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Clarity Medical Systems (Pleasanton, US). The FDA issued a Cleared decision on November 25, 2009 after a review of 289 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 - K090326

510(k) Number K090326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2009
Decision Date November 25, 2009
Days to Decision 289 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
179d slower than avg
Panel avg: 110d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 153
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K090326.
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935 · Centervue S.P.A. · Oct 2010
DIGITAL RETINAL CAMERA CX-1
K092565 · Canon Components, Inc. · Mar 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · Topcon Corp. · Feb 2010
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K092374 · Ophthalmic Imaging Systems · Nov 2009
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K091935 · Tearscience, Inc. · Oct 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
K092056 · Optomed OY · Oct 2009
K090326 · RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
Download PDF FDA Summary Clarity Medical Syste…