Cleared Traditional

K862323 - CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM

K862323 is an FDA 510(k) clearance for CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM, manufactured by Canon USA, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K862323 · Canon USA, Inc. · Ophthalmic device
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Aug 1986
Decision
63d
Days
Class 2
Risk

K862323 is an FDA 510(k) clearance for the CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon USA, Inc. (Jericho, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 63 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 - K862323

510(k) Number K862323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1986
Decision Date August 21, 1986
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
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 K862323.
OPACITY LENSMETER 701
K874355 · Intraoptics, Inc. · Jan 1988
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
K873157 · Holofax , Ltd. · Sep 1987
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · Canon USA, Inc. · Feb 1986
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
K854330 · Par Technology Park · Dec 1985
HUMPHREY IMAGE ANALYZER MODEL 110
K852638 · Zeiss Humphrey System · Aug 1985
K862323 · CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
Download PDF Canon USA, Inc.