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
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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.

View all Clarity Medical Systems devices

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
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 77
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K090326.
KOWA VX-20
K112330 · Kowa Co. , Ltd. · Feb 2012
DIGITAL RETINAL CAMERA
K111612 · Canon, Inc. · Sep 2011
KOWA NONMYD WX
K101628 · Kowa Co. , Ltd. · Jan 2011
KOWAGENESIS-DF
K091098 · Kowa Co. , Ltd. · Aug 2009
KOWA VX-10 A
K091683 · Kowa Co. , Ltd. · Jul 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · Canon, Inc. · Mar 2009