Cleared Special

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) (K244059) - FDA 510(k) Clearance

Also marketed or referenced as:
HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104) HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K244059 · Access Vascular, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
86d
Days
Class 2
Risk

K244059 is an FDA 510(k) clearance for the HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102). Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Access Vascular, Inc. (Billerica, US). The FDA issued a Cleared decision on March 27, 2025 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Access Vascular, Inc. devices

Submission Details

510(k) Number K244059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2024
Decision Date March 27, 2025
Days to Decision 86 days
Submission Type Special
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
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 132
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K244059.
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
K250682 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2025
Ruby Intravascular Catheter
K243105 · Venocare, Inc. · May 2025
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
K250292 · Skydance Vascular, Inc. · May 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
SV Spectrum MRC Central Venous Catheter
K241115 · Spectrum Vascular · Nov 2024