Cleared Traditional

K242429 - CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242429 · Becton Dickinson Inc. (Bd) · General Hospital
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Apr 2025
Decision
237d
Days
Class 2
Risk

K242429 is an FDA 510(k) clearance for the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion Sy.... Classified as Central Venous Catheter With Manual Insertion System (product code SEF), Class II - Special Controls.

Submitted by Becton Dickinson Inc. (Bd) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 9, 2025 after a review of 237 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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.

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Submission Details

510(k) Number K242429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2024
Decision Date April 09, 2025
Days to Decision 237 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 128d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SEF Central Venous Catheter With Manual Insertion System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition A Central Venous Catheter With Manual Insertion System Is Intended To Provide Short-term Access (<30 Days) To The Central Venous System. The Manual Insertion System Is Attached To The Catheter And Facilitates Placement In The Targeted Vessel.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.