Cleared Traditional

PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (K881358) - FDA 510(k) Clearance

Class I Ophthalmic device.

K881358 · Neuroscientific Corp. · Ophthalmic device
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Jun 1988
Decision
88d
Days
Class 1
Risk

K881358 is an FDA 510(k) clearance for the PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Neuroscientific Corp. (Farmingdale, US). The FDA issued a Cleared decision on June 27, 1988 after a review of 88 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 Neuroscientific Corp. devices

Submission Details

510(k) Number K881358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1988
Decision Date June 27, 1988
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
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.