Cleared Traditional

VKG 1000, VIDEO KERATOGRAPH (K901523) - FDA 510(k) Clearance

Class I Ophthalmic device.

K901523 · The Sanborn Co. · Ophthalmic device
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Jun 1990
Decision
86d
Days
Class 1
Risk

K901523 is an FDA 510(k) clearance for the VKG 1000, VIDEO KERATOGRAPH. Classified as Photokeratoscope (product code HJA), Class I - General Controls.

Submitted by The Sanborn Co. (Santa Clara, US). The FDA issued a Cleared decision on June 27, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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 The Sanborn Co. devices

Submission Details

510(k) Number K901523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date June 27, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJA Photokeratoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.