Cleared Traditional

K014044 - MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K014044 · Notal Vision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
87d
Days
Class 1
Risk

K014044 is an FDA 510(k) clearance for the MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT). Classified as Grid, Amsler (product code HOQ), Class I - General Controls.

Submitted by Notal Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1330 - 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 Notal Vision, Inc. devices

Submission Details

510(k) Number K014044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2001
Decision Date March 04, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOQ Grid, Amsler
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1330
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.