Cleared Traditional

SV Spectrum MRC Central Venous Catheter (K241115) - FDA 510(k) Clearance

Also marketed or referenced as:
SV Spectrum MR Central Venous Catheter SV Central Venous Catheter

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

K241115 · Spectrum Vascular · General Hospital
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Nov 2024
Decision
218d
Days
Class 2
Risk

K241115 is an FDA 510(k) clearance for the SV Spectrum MRC Central Venous Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on November 27, 2024 after a review of 218 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.

View all Spectrum Vascular devices

Submission Details

510(k) Number K241115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2024
Decision Date November 27, 2024
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 127
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K241115.
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)
K244059 · Access Vascular, Inc. · Mar 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Mar 2025
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Dec 2024
PowerGlide Pro™ Midline Catheter
K240359 · Becton, Dickinson and Company (Bard Access Systems, Inc.) · Jul 2024
Introcan Safety® 2 IV Catheter
K241845 · B.Braun Medical, Inc. · Jul 2024
AccuCath Ace™ Intravascular Catheter
K233106 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · Apr 2024