Cleared Traditional

K000368 - EYECAP IMAGING SYSTEM

K000368 is an FDA 510(k) clearance for EYECAP IMAGING SYSTEM, manufactured by Clement Clarke Intl., Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000368 · Clement Clarke Intl., Ltd. · Ophthalmic device
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May 2000
Decision
90d
Days
Class 2
Risk

K000368 is an FDA 510(k) clearance for the EYECAP IMAGING SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Clement Clarke Intl., Ltd. (Harlow, GB). The FDA issued a Cleared decision on May 4, 2000 after a review of 90 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 Clement Clarke Intl., Ltd. devices

FDA 510(k) Submission Details - K000368

510(k) Number K000368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date May 04, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K000368.
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
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