Cleared Traditional

K895474 - NON-MYDRIATIC RETINAL CAMERA

K895474 is the FDA 510(k) clearance for NON-MYDRIATIC RETINAL CAMERA by Canon USA, Inc.. It is a Class 2 Ophthalmic device (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.

View all Canon USA, Inc. devices

Submission Details

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.

Device Classification

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 58
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K895474.
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · Canon USA, Inc. · Feb 1994
CANDELA RETINAL CAMERA
K913314 · Candela Laser Corp. · Jan 1992
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · Canon USA, Inc. · Jun 1991
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · Canon USA, Inc. · Aug 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · Canon USA, Inc. · Feb 1986