Cleared Traditional

K041367 - TOPCON MODEL TRC-NW200 NON-MYDRIATIC RE...

K041367 is an FDA 510(k) clearance for TOPCON MODEL TRC-NW200 NON-MYDRIATIC RE..., manufactured by Topcon Corp.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K041367 · Topcon Corp. · Ophthalmic device
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Nov 2004
Decision
165d
Days
Class 2
Risk

K041367 is an FDA 510(k) clearance for the TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Topcon Corp. (Paramus, US). The FDA issued a Cleared decision on November 5, 2004 after a review of 165 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 Topcon Corp. devices

FDA 510(k) Submission Details - K041367

510(k) Number K041367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2004
Decision Date November 05, 2004
Days to Decision 165 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
55d slower than avg
Panel avg: 110d · This submission: 165d
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 K041367.
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
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · Nidek, Inc. · Apr 2002