Cleared Traditional

K895474 - NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL

K895474 is an FDA 510(k) clearance for NON-MYDRIATIC RETINAL CAMERA, 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 23-day FDA review.

K895474 · Canon USA, Inc. · Ophthalmic device
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Oct 1989
Decision
23d
Days
Class 2
Risk

K895474 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon USA, Inc. (Tokyo 146, JP). The FDA issued a Cleared decision on October 4, 1989 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 - K895474

510(k) Number K895474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date October 04, 1989
Days to Decision 23 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
87d faster than avg
Panel avg: 110d · This submission: 23d
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 K895474.
CANDELA RETINAL CAMERA
K913314 · Candela Laser Corp. · Jan 1992
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
K913929 · Ophthalmic Imaging Systems · Nov 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · Canon USA, Inc. · Jun 1991
NEVISCAN MODEL N - 100
K884989 · Special Products, Inc. · Feb 1989
OPACITY LENSMETER 701
K874355 · Intraoptics, Inc. · Jan 1988
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987
K895474 · NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
Download PDF Canon USA, Inc.