Cleared Traditional

K843021 - CANON 60 FUNDUS CAMERA CF-60U

K843021 is an FDA 510(k) clearance for CANON 60 FUNDUS CAMERA CF-60U, 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 65-day FDA review.

K843021 · Canon USA, Inc. · Ophthalmic device
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Oct 1984
Decision
65d
Days
Class 2
Risk

K843021 is an FDA 510(k) clearance for the CANON 60 FUNDUS CAMERA CF-60U. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon USA, Inc. (Melville, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 65 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 - K843021

510(k) Number K843021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1984
Decision Date October 05, 1984
Days to Decision 65 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
45d faster than avg
Panel avg: 110d · This submission: 65d
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 K843021.
HUMPHREY IMAGE ANALYZER MODEL 110
K852638 · Zeiss Humphrey System · Aug 1985
GRC-WT, GRC-W
K843899 · Olympus Corp. · Jan 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898 · Canon USA, Inc. · Jan 1985
TEXAS BIO SCAN
K833694 · Texas Bio Scan · Mar 1984
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K822991 · Warner-Lambert Co. · Feb 1983
COHERENT FUNDUSL RETINAL CAMERA
K822908 · Coherent Medical Division · Jan 1983
K843021 · CANON 60 FUNDUS CAMERA CF-60U
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