Cleared Traditional

K891610 - HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K891610 · Keeler Instruments, Inc. · Ophthalmic device
Jun 1989
Decision
77d
Days
Class 1
Risk

K891610 is an FDA 510(k) clearance for the HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER. Classified as Clamp, Eyelid, Ophthalmic (product code HOD), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 5, 1989 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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.

Submission Details

510(k) Number K891610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date June 05, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 156d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOD Clamp, Eyelid, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.