Cleared Traditional

K911439 - NON-MYDRIATIC RETINAL CAMERA, CR-45UAF

K911439 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 76-day FDA review.

K911439 · Canon USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
76d
Days
Class 2
Risk

K911439 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, CR-45UAF. 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 June 17, 1991 after a review of 76 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 - K911439

510(k) Number K911439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1991
Decision Date June 17, 1991
Days to Decision 76 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
34d faster than avg
Panel avg: 110d · This submission: 76d
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 K911439.
CHROMOS IMAGER
K923958 · Chromos Imaging, Inc. · Mar 1993
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, CR4-45NM DUAL
K895474 · Canon USA, Inc. · Oct 1989
NEVISCAN MODEL N - 100
K884989 · Special Products, Inc. · Feb 1989
OPACITY LENSMETER 701
K874355 · Intraoptics, Inc. · Jan 1988
K911439 · NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
Download PDF Canon USA, Inc.