Cleared Traditional

ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (K873914) - FDA 510(k) Clearance

Class I Ophthalmic device.

K873914 · Richmond Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
77d
Days
Class 1
Risk

K873914 is an FDA 510(k) clearance for the ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT). Classified as Device, Fixation, Ac-powered, Ophthalmic (product code HPL), Class I - General Controls.

Submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1290 - 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 Richmond Products, Inc. devices

Submission Details

510(k) Number K873914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date December 11, 1987
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPL Device, Fixation, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1290
Definition A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.)
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.