Cleared Traditional

K043213 - KOWA VX-10

K043213 is an FDA 510(k) clearance for KOWA VX-10, manufactured by Kowa Co. , Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K043213 · Kowa Co. , Ltd. · Ophthalmic device
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Oct 2005
Decision
321d
Days
Class 2
Risk

K043213 is an FDA 510(k) clearance for the KOWA VX-10. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Kowa Co. , Ltd. (Rockville, US). The FDA issued a Cleared decision on October 6, 2005 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kowa Co. , Ltd. devices

FDA 510(k) Submission Details - K043213

510(k) Number K043213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2004
Decision Date October 06, 2005
Days to Decision 321 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
211d slower than avg
Panel avg: 110d · This submission: 321d
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 61
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K043213.
CR-1
K080883 · Canon, Inc. · Apr 2008
CF-1
K063717 · Canon, Inc. · Jan 2007
VISUCAM PRO NM
K052268 · Carl Zeiss Meditec, AG · Nov 2005
VISCUCAM C DIGITAL CAMERA
K043222 · Carl Zeiss Meditec, AG · Feb 2005
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546 · Canon, Inc. · Jun 2004
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · Canon USA, Inc. · Jun 2003