Cleared Traditional

K113451 - NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX

K113451 is an FDA 510(k) clearance for NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-33..., manufactured by Nidek Technologies Srl. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K113451 · Nidek Technologies Srl · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
169d
Days
Class 2
Risk

K113451 is an FDA 510(k) clearance for the NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Nidek Technologies Srl (Albignasego (Padova), IT). The FDA issued a Cleared decision on May 8, 2012 after a review of 169 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 - K113451

510(k) Number K113451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date May 08, 2012
Days to Decision 169 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
59d slower than avg
Panel avg: 110d · This submission: 169d
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 146
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K113451.
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K112330 · Kowa Co. , Ltd. · Feb 2012
NON-CONTACT TEAR FILM THERMOGRAGH
K111771 · United Integrated Services Co., Ltd. · Nov 2011
DIGITAL RETINAL CAMERA
K111612 · Canon, Inc. · Sep 2011
K113451 · NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
Download PDF FDA Summary Nidek Technologies Srl