Cleared Traditional

K895474 - NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895474 · Canon USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 155
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K895474.
Eyer 2
K251353 · Phelcom Technologies · Jan 2026
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · Remidio Innovative Solutions Private Limited · Dec 2025
Optina-4C (MHRC-C1N)
K250770 · Optina Diagnostics, Inc. · Sep 2025
3nethra neo HD FA
K243600 · Forus Health Pvt.Ltd · Aug 2025
Resolve Fundus Camera
K250683 · Optain Health, Inc. · Apr 2025
Sentinel Camera
K243664 · Ai Optics · Dec 2024