Who is the manufacturer of BD Nexiva Closed IV Catheter System?

Becton Dickinson Infusion Therapy Systems, Inc. filed the 510(k) submission for BD Nexiva Closed IV Catheter System (K183399).

What is the FDA product code for BD Nexiva Closed IV Catheter System?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BD Nexiva Closed IV Catheter System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BD Nexiva Closed IV Catheter System?

BD Nexiva™ Closed IV Catheter System - Single Port with MaxZero™ Needleless Connector (K170336); BD Nexiva™ Closed IV Catheter System (K161777).

Who can help prepare an FDA 510(k) submission like BD Nexiva Closed IV Catheter System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD Nexiva Closed IV Catheter System

K183399 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Mar 20, 2019 · General Hospital

Device Facts

Record ID	K183399
Device Name	BD Nexiva Closed IV Catheter System
Applicant	Becton Dickinson Infusion Therapy Systems, Inc.
Product Code	FOZ · General Hospital
Decision Date	Mar 20, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended Use

BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

Device Story

Over-the-needle peripheral IV catheter system; includes radiopaque polyurethane catheter, needle, needle shield, septum, stabilization platform, extension tubing, clamp, Luer adapter, and pre-attached MaxZero needleless connector. Features BD Instaflash technology for immediate blood visualization; septum wipes needle during withdrawal to reduce blood exposure; passive needle tip protection. Used in clinical settings by healthcare providers for vascular access. Device maintains closed system to contain blood during insertion. Output is venous access for fluid/medication delivery, blood sampling, or pressure monitoring. Benefits include reduced needlestick injury risk and minimized blood exposure.

Clinical Evidence

Bench testing only. Performance testing included MaxZero retention rate, removal torque, flow control plug retention, packaging integrity (ASTM F2096), and device damage (ISO 11607-1). Biocompatibility testing leveraged from predicates per ISO 10993-1, including cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, genotoxicity, and haemocompatibility.

Technological Characteristics

Materials: Stainless steel needle, polyurethane/barium sulfate catheter, TPE/copolyester adapters, polycarbonate tip shield/hub, acetal clamp. Sensing/Actuation: Passive needle protection, Instaflash flashback visualization. Energy: None. Connectivity: None. Sterilization: Ethylene Oxide (EO). Form factor: Over-the-needle catheter with integrated extension set.

Indications for Use

Indicated for insertion into peripheral vascular system for short-term blood sampling, blood pressure monitoring, or fluid administration. Suitable for all patient populations based on vascular anatomy, procedure, and therapy duration. 22-18 GA models compatible with power injectors up to 300 psi.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

BD Nexiva™ Closed IV Catheter System - Single Port with MaxZero™ Needleless Connector (K170336)
BD Nexiva™ Closed IV Catheter System (K161777)

Related Devices

K170283 — BD Nexiva Diffusics Closed IV Catheter System · Becton, Dickinson and Company · Feb 28, 2017
K233529 — BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 1, 2023
K243403 — BD Nexiva Closed IV Catheter System · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 25, 2025
K231239 — Nexiva Closed IV Catheter System with NearPort IV Access · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 22, 2023
K170336 — BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector · Becton, Dickinson and Company · Mar 10, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 20, 2019 Becton Dickinson Infusion Therapy Systems Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313 Re: K183399 Trade/Device Name: BD Nexiva™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: March 11, 2019 Received: March 12, 2019 Dear Mark Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Geeta K. Pamidimukkala -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183399 Device Name BD Nexiva Closed IV Catheter System #### Indications for Use (Describe) BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sun-like symbol in orange and the letters "BD" in blue. The sun-like symbol is on the left, and the letters "BD" are on the right. The logo is simple and modern, and it is easily recognizable. ## K183399 ## 510(k) Summary (21 CFR §807.92) ## BD Nexiva™ Closed IV Catheter System | Submitter Information | Submitter Name: Submitter Address: Contact Person: Email Address: Phone Number: Fax Number Date of Preparation: | Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 Kimberly Geisler Regulatory Affairs Manager kimberly.geisler@bd.com (801) 565-2422 (801) 304-3963 March 14, 2019 | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: | BD Nexiva™ Closed IV Catheter System Peripheral Intravascular or IV Catheter 21 CFR §880.5200 Catheter, intravascular, therapeutic, short-term less than 30 days II FOZ (Primary); FPA (Secondary) General Hospital | | Predicate Device 1 | Trade Name: 510(k) Reference: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: | BD Nexiva™ Closed IV Catheter System - Single Port with MaxZero™ Needleless Connector K170336 Peripheral Intravascular or IV Catheter 21 CFR §880.5200 Catheter, intravascular, therapeutic, short-term less than 30 days II FOZ (primary); FPA (secondary) General Hospital | | Predicate Device 2 | Trade Name: 510(k) Reference: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: | BD Nexiva™ Closed IV Catheter System K161777 Peripheral Intravascular or IV Catheter 21 CFR §880.5200 Catheter, intravascular, therapeutic, short-term less than 30 days II FOZ General Hospital | | Reason for Submission | The reason for this submission is the addition of BD Nexiva Closed IV Catheter System - Dual Port with MaxZero Needleless Connector configurations to the BD Nexiva Closed IV Catheter System product offerings. | | | Device Description | BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and pre-attached needleless connector (BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with protective cover is provided in the unit package (not available with all configurations). | | | | The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. | | | | These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green). | | | Indications for Use 21 CFR §807.92(a)(5)) | The subject device Indications for Use is the same as the predicate devices, with two minor wording modifications: 1) addition of "peripheral" to clarify the location of placement within the patient's vascular system; and 2) modification of "These catheters" to "These devices" for clarification and consistency. | | | | BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | | | Technological Characteristics | Technological characteristics of the subject and predicate devices are substantially equivalent with respect to the device design and materials. The subject BD Nexiva Closed IV Catheter System achieves its intended use based on the same technology and principles of operation as the predicate devices. | | | | Compared to the predicate devices, the subject device product offerings are being expanded to include the following BD Nexiva Closed IV Catheter System – Dual Port with MaxZero Needleless Connector configurations: | | | | 24 GA x 0.56 IN - Dual Port with MaxZero 24 GA x 0.75 IN - Dual Port with MaxZero 22 GA x 1.00 IN - Dual Port with MaxZero 22 GA x 1.75 IN – Dual Port with MaxZero 20 GA x 1.00 IN - Dual Port with MaxZero 20 GA x 1.25 IN - Dual Port with MaxZero 20 GA x 1.75 IN - Dual Port with MaxZero 18 GA x 1.25 IN - Dual Port with MaxZero | | {4}------------------------------------------------ Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA bd.com {5}------------------------------------------------ #### 18 GA x 1.75 IN - Dual Port with MaxZero ● Compared to the predicate devices, the subject BD Nexiva Closed IV Catheter System - Dual Port with MaxZero Needleless Connector configurations include a pre-attached MaxZero device on the Luer adapter and an additional MaxZero device in the unit package. Compared to the predicate devices, this represents a change to the connector on the Dual Port Y Luer adapter. No modifications are being made to the catheter sizes. Predicate and subject devices include the same catheter diameters (18 GA, 20 GA, 22 GA, 24GA) and catheter lengths (0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN). | Attribute | SUBJECT BD Nexiva Closed IV Catheter System | PREDICATE 1 (K170336) BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector | PREDICATE 2 (K161777) BD Nexiva Closed IV Catheter System | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22- 18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | BD Nexiva closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | | Classification | 21 CFR §880.5200 Class II FOZ - Catheter, intravascular, therapeutic, short-term less than 30 days (primary) FPA - IV Administration Set (secondary) | 21 CFR §880.5200 Class II FOZ - Catheter, intravascular, therapeutic, short-term less than 30 days (primary) FPA - IV Administration Set (secondary) | 21 CFR §880.5200 Class II FOZ - Catheter, intravascular, therapeutic, short-term less than 30 days (primary) | | 510(k) Status | Subject of this premarket notification | K170336 - Clearance date March 10, 2017 | K161777 - Clearance date August 29, 2016 | | Fundamental Scientific Technology | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization. | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization. | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates BD Instaflash ™ technology to assist with flashback visualization. | | | Primary Device Components / Materials | | | | Needle | Stainless Steel | Stainless Steel | Stainless Steel | | Catheter Tubing | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | | Catheter Adapter Wings | TPE + Gauge-Specific Colorant | TPE + Gauge-Specific Colorant | TPE + Gauge-Specific Colorant | | Catheter Adapter | Copolyester | Copolyester | Copolyester | | Tip Shield | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant | | Grip / Needle Hub | Polycarbonate + White Colorant | Polycarbonate + White Colorant | Polycarbonate + White Colorant | | Pinch Clamp | Acetal | Acetal | Acetal | | Extension Tubing | Polyurethane | Polyurethane | Polyurethane | | Luer Adapter | Copolyester | Copolyester | Copolyester | | Q-Syte | Polycarbonate / Silicone | N/A | Polycarbonate / Silicone | | MaxZero | Polycarbonate / Silicone | Polycarbonate / Silicone | N/A | | | Catheter Diameters | Catheter Diameters | Catheter Diameters | | Catheter Dimensions | 18 GA, 20 GA, 22 GA, 24GA | 18 GA, 20 GA, 22 GA, 24GA | 18 GA, 20 GA, 22 GA, 24GA | | | Catheter Lengths | Catheter Lengths | Catheter Lengths | | | 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | | | • Single Port | • Single Port | • Single Port | | | • Single Port with MaxZero | • Single Port with MaxZero | N/A | | Product Configurations | • Dual Port | N/A | • Dual Port | | | • Dual Port with Q-Syte | N/A | • Dual Port with Q-Syte | | | • Dual Port with Q-Syte and End Cap | N/A | • Dual Port with Q-Syte and End Cap | | | • Dual Port with MaxZero | N/A | N/A | | Sterility | Provided sterile (EO) | Provided sterile (EO) | Provided sterile (EO) | A comparison of the subject and predicate device technological characteristics is provided in the table below, with differences highlighted in BOLD text. {6}------------------------------------------------ {7}------------------------------------------------ | Summary of Performance Tests | Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets specified design requirements: | |-------------…

BD Nexiva Closed IV Catheter System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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BD Nexiva Closed IV Catheter System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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