Cleared Traditional

K022164 - ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM

K022164 is an FDA 510(k) clearance for ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM, manufactured by Zeta Development Laboratories. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K022164 · Zeta Development Laboratories · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
23d
Days
Class 2
Risk

K022164 is an FDA 510(k) clearance for the ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Zeta Development Laboratories (El Dorado Hills, US). The FDA issued a Cleared decision on July 26, 2002 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022164

510(k) Number K022164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date July 26, 2002
Days to Decision 23 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 110d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MICHAEL KWAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K022164.
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · Canon USA, Inc. · Jun 2003
MP-1 MICRO PERIMETER
K023719 · Nidek Technologies Srl · Dec 2002
FUNDUS AUTOIMAGER
K020888 · Visual Pathways, Inc. · Nov 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
ISCREEN VISION SCREENER
K010315 · Iscreen, LLC · Jun 2001
K022164 · ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
Download PDF FDA Summary Zeta Development Labo…