Cleared Traditional

K893968 - VKG 2000 VIDEO KERATOMETER

K893968 is an FDA 510(k) clearance for VKG 2000 VIDEO KERATOMETER, manufactured by Technitex, Inc.. The device is a Class 1 Ophthalmic device with product code HJA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K893968 · Technitex, Inc. · Ophthalmic device
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Sep 1989
Decision
101d
Days
Class 1
Risk

K893968 is an FDA 510(k) clearance for the VKG 2000 VIDEO KERATOMETER. Classified as Photokeratoscope (product code HJA), Class I - General Controls.

Submitted by Technitex, Inc. (Houston, US). The FDA issued a Cleared decision on September 11, 1989 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Technitex, Inc. devices

FDA 510(k) Submission Details - K893968

510(k) Number K893968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1989
Decision Date September 11, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 110d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

HJA Device Classification - Class 1, General Controls

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.