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FDA 510(k)

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

K-Number: K250682 · 2025-06-03

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date2025-06-03
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K250682. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector?

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K250682.

When did BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector receive FDA 510(k) clearance?

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector received FDA 510(k) clearance on 2025-06-03, under 510(k) number K250682.

Who is the listed applicant for BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector?

The FDA product code for BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector is FOZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06806709Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)RECRUITINGNCT07515040Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- GuidanceRECRUITINGNCT07519304Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical TrialNOT_YET_RECRUITING

Other records listing Becton Dickinson Infusion Therapy Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252137BD Insyte™ IV CatheterK251422BD Saf-T-Intima™ Subcutaneous Catheter SystemK243403BD Nexiva™ Closed IV Catheter SystemK251155BD Cathena™ Safety IV CatheterK251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterK241586PIVO™ Pro Needle-free Blood Collection Device

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Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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