Cleared Special

Health Line CT Midline Catheter (K200263) - FDA 510(k) Clearance

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

K200263 · Health Line International Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
38d
Days
Class 2
Risk

K200263 is an FDA 510(k) clearance for the Health Line CT Midline Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on March 12, 2020 after a review of 38 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 Health Line International Corporation devices

Submission Details

510(k) Number K200263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date March 12, 2020
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 138
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K200263.
MF SAFECATH
K192230 · Medifirst Co., Ltd. · Apr 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Apr 2020
Introcan Safety 2 IV Catheter 18-24 gauge
K192676 · B.Braun Medical, Inc. · Apr 2020
BD Cathena (TM) Safety IV Catheter
K192493 · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 2020
Health Line CT CVC
K192533 · Health Line International Corporation · Dec 2019
BD Acute Central Line
K190855 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Nov 2019