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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 156
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K010315.
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164 · Zeta Development Laboratories · Jul 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · Nidek, Inc. · Apr 2002
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
K011877 · Carl Zeiss Jena GmbH · Sep 2001
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920 · Escalon Medical Corp. · Dec 2000
RETINADX
K003236 · Regulatory Associates, Inc. · Nov 2000
RETCAM II
K001275 · Massie Research Laboratories, Inc. · Jul 2000
K010315 · ISCREEN VISION SCREENER
Download PDF FDA Summary Iscreen, LLC