Cleared Traditional

K003236 - RETINADX

K003236 is an FDA 510(k) clearance for RETINADX, manufactured by Regulatory Associates, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K003236 · Regulatory Associates, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
16d
Days
Class 2
Risk

K003236 is an FDA 510(k) clearance for the RETINADX. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Regulatory Associates, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 2, 2000 after a review of 16 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 - K003236

510(k) Number K003236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date November 02, 2000
Days to Decision 16 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 110d · This submission: 16d
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 K003236.
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
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920 · Escalon Medical Corp. · Dec 2000
RETCAM II
K001275 · Massie Research Laboratories, Inc. · Jul 2000
EYECAP IMAGING SYSTEM
K000368 · Clement Clarke Intl., Ltd. · May 2000
DIGISCOPE OPHTHALMIC CAMERA
K990205 · Eye Tel Imaging, Inc. · Mar 1999
K003236 · RETINADX
Download PDF Regulatory Associates…