Cleared Special

K241049 - CANON Fundus Camera CR-10 (CR-10)

K241049 is an FDA 510(k) clearance for CANON Fundus Camera CR-10 (CR-10), manufactured by Canon, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 28-day FDA review.

K241049 · Canon, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
28d
Days
Class 2
Risk

K241049 is an FDA 510(k) clearance for the CANON Fundus Camera CR-10 (CR-10). Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon, Inc. (Kawasaki, JP). The FDA issued a Cleared decision on May 15, 2024 after a review of 28 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.

FDA 510(k) Submission Details - K241049

510(k) Number K241049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2024
Decision Date May 15, 2024
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Ora, Inc.
Roger Albright

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 156
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K241049 · CANON Fundus Camera CR-10 (CR-10)
Download PDF FDA Summary Canon, Inc.