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)
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.

View all Zeta Development Laboratories devices

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
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 Peers - HKI Camera, Ophthalmic, Ac-powered

All 102
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K022164.
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K990205 · Eye Tel Imaging, Inc. · Mar 1999
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