Cleared Traditional

K853736 - MENTOR BRIGHTNESS ACUITY TESTER

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

K853736 · Mentor O & O, Inc. · Ophthalmic device
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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

FDA 510(k) Submission Details - K853736

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

HOX Device Classification - Class 1, General Controls

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

All 8
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
MENTOR B-VAT(TM) II VIDEO TESTER
K875112 · Mentor O & O, Inc. · Mar 1988
CANON AUTO ACUITOMETER CV-10
K861416 · Canon USA, Inc. · May 1986
VFS 1000/SCREENING FUNCTION ANALYZER
K830011 · CooperVision, Inc. · Jan 1983
NIC OPTRONICS CS-2000
K822215 · Nicolet Biomedical Instruments · Aug 1982
MENTOR POTENTIAL ACUITY METER
K821932 · Mentor O & O, Inc. · Aug 1982