Cleared Traditional

K852638 - HUMPHREY IMAGE ANALYZER MODEL 110

K852638 is an FDA 510(k) clearance for HUMPHREY IMAGE ANALYZER MODEL 110, manufactured by Zeiss Humphrey System. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K852638 · Zeiss Humphrey System · Ophthalmic device
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Aug 1985
Decision
53d
Days
Class 2
Risk

K852638 is an FDA 510(k) clearance for the HUMPHREY IMAGE ANALYZER MODEL 110. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Zeiss Humphrey System (San Leandro, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 53 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 Zeiss Humphrey System devices

FDA 510(k) Submission Details - K852638

510(k) Number K852638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date August 12, 1985
Days to Decision 53 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 110d · This submission: 53d
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 116
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K852638.
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · Canon USA, Inc. · Aug 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · Canon USA, Inc. · Feb 1986
GRC-WT, GRC-W
K843899 · Olympus Corp. · Jan 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898 · Canon USA, Inc. · Jan 1985
CANON 60 FUNDUS CAMERA CF-60U
K843021 · Canon USA, Inc. · Oct 1984