Cleared Traditional

K010315 - ISCREEN VISION SCREENER

K010315 is an FDA 510(k) clearance for ISCREEN VISION SCREENER, manufactured by Iscreen, LLC. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K010315 · Iscreen, LLC · Ophthalmic device
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Jun 2001
Decision
119d
Days
Class 2
Risk

K010315 is an FDA 510(k) clearance for the ISCREEN VISION SCREENER. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Iscreen, LLC (Memphis, US). The FDA issued a Cleared decision on June 1, 2001 after a review of 119 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 Iscreen, LLC devices

FDA 510(k) Submission Details - K010315

510(k) Number K010315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date June 01, 2001
Days to Decision 119 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
9d slower than avg
Panel avg: 110d · This submission: 119d
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 105
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K010315.
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
DIGISCOPE OPHTHALMIC CAMERA
K990205 · Eye Tel Imaging, Inc. · Mar 1999
WINSTATION RETINAL IMAGER
K982689 · Ophthalmic Imaging Systems · Oct 1998
DISCAM DIGITAL IMAGING SYSTEM
K974535 · Marcher Enterprises, Ltd. · Aug 1998