Cleared Traditional

K924447 - VITAPEN

K924447 is an FDA 510(k) clearance for VITAPEN, manufactured by Vitajet Corp.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K924447 · Vitajet Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K924447

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.

KZF Device Classification - Class 1, General Controls

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.

Regulatory Peers - KZF Device, Medical Examination, Ac Powered

All 15
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K924447.
CHROMOPHARE
K935832 · Berchtold Holding GmbH · Feb 1994
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · Welch Allyn, Inc. · Jan 1994
RITTER MODEL 158 AND 159 EXAM LIGHTS
K932719 · Midmark Corp. · Dec 1993
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
K921493 · Welch Allyn, Inc. · Nov 1992
EXAMINATION LAMP
K922150 · Air-Shields, Inc. · Jul 1992
EPISCOPE, MODEL 47300
K920103 · Welch Allyn, Inc. · Apr 1992