Cleared Traditional

K014274 - NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

K014274 is an FDA 510(k) clearance for NON-MYDRIATIC FUNDUS CAMERA, manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K014274 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
111d
Days
Class 2
Risk

K014274 is an FDA 510(k) clearance for the NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 111 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 Nidek, Inc. devices

FDA 510(k) Submission Details - K014274

510(k) Number K014274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2001
Decision Date April 17, 2002
Days to Decision 111 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
1d slower than avg
Panel avg: 110d · This submission: 111d
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 112
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K014274.
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