Cleared Traditional

K020888 - FUNDUS AUTOIMAGER

K020888 is an FDA 510(k) clearance for FUNDUS AUTOIMAGER, manufactured by Visual Pathways, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K020888 · Visual Pathways, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
234d
Days
Class 2
Risk

K020888 is an FDA 510(k) clearance for the FUNDUS AUTOIMAGER. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Visual Pathways, Inc. (Prescott, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 234 days - an extended review cycle.

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 - K020888

510(k) Number K020888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date November 07, 2002
Days to Decision 234 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
124d slower than avg
Panel avg: 110d · This submission: 234d
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 K020888.
PANORET, MODEL PNM 60
K040325 · Medibell Medical Vision Technologies , Ltd. · Mar 2004
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · Canon USA, Inc. · Jun 2003
MP-1 MICRO PERIMETER
K023719 · Nidek Technologies Srl · Dec 2002
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
K020888 · FUNDUS AUTOIMAGER
Download PDF FDA Summary Visual Pathways, Inc.