Cleared Traditional

K181208 - Vygon Midline 3 Fr SL Catheter (FDA 510(k) Clearance)

Also includes:
Vygon Midline 4 Fr SL Catheter Vygon Midline 5 Fr DL Catheter

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

K181208 · Vygon USA · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
179d
Days
Class 2
Risk

K181208 is an FDA 510(k) clearance for the Vygon Midline 3 Fr SL Catheter. Classified as Midline Catheter (product code PND), Class II - Special Controls.

Submitted by Vygon USA (Lansdale, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 179 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 Vygon USA devices

Submission Details

510(k) Number K181208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2018
Decision Date November 02, 2018
Days to Decision 179 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 128d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PND Midline Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
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 - PND Midline Catheter

All 12
Devices cleared under the same product code (PND) and FDA review panel - the closest regulatory comparables to K181208.
Midline Catheter
K252402 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Arrow Pressure Injectable Midline Catheter
K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · Sep 2022
Provena(TM) Midline Catheter
K213203 · C.R. Bard, Inc. · May 2022
Stiletto Extended Dwell Catheter
K210047 · Piper Access, LLC · Aug 2021