Cleared Special

K102520 - BD NEXIVA CLOSED IV CATHETER SYSTEM

K102520 is an FDA 510(k) clearance for BD NEXIVA CLOSED IV CATHETER SYSTEM, manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 126-day FDA review.

K102520 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
126d
Days
Class 2
Risk

K102520 is an FDA 510(k) clearance for the BD NEXIVA CLOSED IV CATHETER SYSTEM. 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 January 6, 2011 after a review of 126 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K102520

510(k) Number K102520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2010
Decision Date January 06, 2011
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Modification to existing cleared device.

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 K102520.
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
K112347 · Vascular Pathways, Inc. · Sep 2011
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
K111236 · B.Braun Melsungen AG · Aug 2011
BD INSYTE AUTOGUARD BC
K110443 · Becton, Dickinson & CO · Jul 2011
BD INTIMA II CLOSED IV CATHETER
K100775 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2010
SPECTRUM TURBO-JECT PICC SET
K100974 · Cook Incorporated · May 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
K100282 · Terumo Corp. · Feb 2010