Cleared Traditional

K864467 - HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN (FDA 510(k) Clearance)

Class I Ophthalmic device.

K864467 · Keeler Instruments, Inc. · Ophthalmic device
Dec 1986
Decision
33d
Days
Class 1
Risk

K864467 is an FDA 510(k) clearance for the HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN. Classified as Perimeter, Ac-powered (product code HOO), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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 K864467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date December 15, 1986
Days to Decision 33 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 156d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOO Perimeter, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.