Cleared Traditional

VITAPEN (K924447) - FDA 510(k) Clearance

Class I General Hospital device.

K924447 · Vitajet Corp. · General Hospital
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Sep 1993
Decision
391d
Days
Class 1
Risk

K924447 is an FDA 510(k) clearance for the VITAPEN. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Vitajet Corp. (Laguna Hills, US). The FDA issued a Cleared decision on September 27, 1993 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitajet Corp. devices

Submission Details

510(k) Number K924447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date September 27, 1993
Days to Decision 391 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 129d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
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.