Cleared Traditional

K014274 - NON-MYDRIATIC FUNDUS CAMERA

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

K014274 · Nidek, Inc. · Ophthalmic device
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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

Submission Details

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.

Device Classification

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 58
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K014274.
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 RETINAL CAMERA, MODEL CR6-45NM
K980246 · Canon USA, Inc. · May 1998
NIDEK HANDY
K973218 · Nidek, Inc. · Nov 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533 · Nidek, Inc. · Nov 1997