Cleared Traditional

K895993 - VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE (FDA 510(k) Clearance)

Class I General Hospital device.

K895993 · Vitaphore Corp. · General Hospital
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Jan 1990
Decision
90d
Days
Class 1
Risk

K895993 is an FDA 510(k) clearance for the VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - 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. Standard predicate reliance. 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 Vitaphore Corp. devices

Submission Details

510(k) Number K895993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date January 11, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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.