Cleared Traditional

K141481 - TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

K141481 is an FDA 510(k) clearance for TRC-NW400 NON-MYDRIATIC RETINAL CAMERA, manufactured by Topcon Corporation. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K141481 · Topcon Corporation · Ophthalmic device
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Sep 2014
Decision
105d
Days
Class 2
Risk

K141481 is an FDA 510(k) clearance for the TRC-NW400 NON-MYDRIATIC RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Topcon Corporation (North Reading, US). The FDA issued a Cleared decision on September 17, 2014 after a review of 105 days - within the typical 510(k) review window.

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 Corporation devices

FDA 510(k) Submission Details - K141481

510(k) Number K141481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2014
Decision Date September 17, 2014
Days to Decision 105 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
5d faster than avg
Panel avg: 110d · This submission: 105d
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 Consultant

Topcon Corp.
MAUREEN O'CONNELL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 135
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