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FDA 510(k)

PIVO™ Pro Needle-free Blood Collection Device

K-Number: K241586 · 2025-02-27

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date2025-02-27
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PIVO™ Pro Needle-free Blood Collection Device 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 2025-02-27 under 510(k) number K241586. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIVO™ Pro Needle-free Blood Collection Device?

PIVO™ Pro Needle-free Blood Collection Device is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K241586.

When did PIVO™ Pro Needle-free Blood Collection Device receive FDA 510(k) clearance?

PIVO™ Pro Needle-free Blood Collection Device received FDA 510(k) clearance on 2025-02-27, under 510(k) number K241586.

Who is the listed applicant for PIVO™ Pro Needle-free Blood Collection Device?

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 PIVO™ Pro Needle-free Blood Collection Device?

The FDA product code for PIVO™ Pro Needle-free Blood Collection Device is JKA.

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)RECRUITINGNCT06816979Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung CancerNOT_YET_RECRUITING

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Related Devices (Code: JKA)

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.

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

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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