Cleared Traditional

K853736 - MENTOR BRIGHTNESS ACUITY TESTER

K853736 is the FDA 510(k) clearance for MENTOR BRIGHTNESS ACUITY TESTER by Mentor O & O, Inc.. It is a Class 1 Ophthalmic device (product code HOX) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K853736 · Mentor O & O, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
56d
Days
Class 1
Risk

K853736 is an FDA 510(k) clearance for the MENTOR BRIGHTNESS ACUITY TESTER. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Mentor O & O, Inc. (Hingham, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - 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 Mentor O & O, Inc. devices

Submission Details

510(k) Number K853736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date November 01, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
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.

Regulatory Peers - HOX Chart, Visual Acuity

Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K853736.
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
K880647 · Fred Sammons, Inc. · Apr 1988
CANON AUTO ACUITOMETER CV-10
K861416 · Canon USA, Inc. · May 1986
VFS 1000/SCREENING FUNCTION ANALYZER
K830011 · CooperVision, Inc. · Jan 1983
EYE CHARTS
K813376 · Abco Dealers, Inc. · Jan 1982
BAYLOW VISUAL ACUITY TESTER
K781452 · Codman & Shurtleff, Inc. · Oct 1978