Cleared Special

K201122 - Canon non-mydriatic retinal camera CR s...

K201122 is the FDA 510(k) clearance for Canon non-mydriatic retinal camera CR s... by Canon, Inc.. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Special 510(k) pathway after a 87-day FDA review.

K201122 · Canon, Inc. · Ophthalmic device
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Jul 2020
Decision
87d
Days
Class 2
Risk

K201122 is an FDA 510(k) clearance for the Canon non-mydriatic retinal camera CR series. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon, Inc. (Nakahara-Ku, Kawasaki, JP). The FDA issued a Cleared decision on July 23, 2020 after a review of 87 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Canon, Inc. devices

Submission Details

510(k) Number K201122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2020
Decision Date July 23, 2020
Days to Decision 87 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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
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