Cleared Traditional

K943147 - STATLOCK CV

K943147 is an FDA 510(k) clearance for STATLOCK CV, manufactured by Venetec, Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K943147 · Venetec, Inc. · General Hospital
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Sep 1994
Decision
91d
Days
Class 1
Risk

K943147 is an FDA 510(k) clearance for the STATLOCK CV. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Venetec, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 91 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 Venetec, Inc. devices

FDA 510(k) Submission Details - K943147

510(k) Number K943147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1994
Decision Date September 29, 1994
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

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.

Regulatory Peers - KMK Device, Intravascular Catheter Securement

All 14
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K943147.
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