Cleared Traditional

K143610 - BD INTIMA II CLOSED IV CATHETER

K143610 is an FDA 510(k) clearance for BD INTIMA II CLOSED IV CATHETER, manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K143610 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
111d
Days
Class 2
Risk

K143610 is an FDA 510(k) clearance for the BD INTIMA II CLOSED IV CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on April 9, 2015 after a review of 111 days - within the typical 510(k) review window.

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 Becton Dickinson Infusion Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K143610

510(k) Number K143610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2014
Decision Date April 09, 2015
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 399
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K143610.
I.V. Catheter
K142797 · Jiangxi Sanxin Medtec Co., Ltd. · Jun 2015
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
K150109 · Arrow International (A Subsidiary of Teleflex, Inc.) · Jun 2015
BioFlo Midline Catheter
K150407 · Navilyst Medical, Inc. · May 2015
ACCUCATH MIDLINE CATHETER SYSTEM
K142136 · Vascular Pathways, Inc. · Jan 2015
NEXUS MIDLINE CT CATHETER
K140270 · Health Line International Corporation · Aug 2014
LEADERFLEX
K141026 · Vygon · Jul 2014