Cleared Traditional

VKG 1000, VIDEO KERATOMETER (K883471) - FDA 510(k) Clearance

Class I Ophthalmic device.

K883471 · Technitex, Inc. · Ophthalmic device
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Nov 1988
Decision
84d
Days
Class 1
Risk

K883471 is an FDA 510(k) clearance for the VKG 1000, VIDEO KERATOMETER. Classified as Target, Fusion And Stereoscopic (product code HLP), Class I - General Controls.

Submitted by Technitex, Inc. (Houston, US). The FDA issued a Cleared decision on November 8, 1988 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1880 - 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 Technitex, Inc. devices

Submission Details

510(k) Number K883471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date November 08, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLP Target, Fusion And Stereoscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1880
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.