Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

K-Number: K260128 · 2026-04-15

ApplicantBecton, Dickinson and Company
Decision Date2026-04-15
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260128. 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 BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K260128.

When did BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes receive FDA 510(k) clearance?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260128.

Who is the listed applicant for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

The FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes 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.

NCT05957406SMART TRENDS StudyCOMPLETEDNCT06492746Personal BP - CAI StudyRECRUITINGNCT07148323HemoSphere Alta StudyRECRUITINGNCT07216573The Continuity StudyRECRUITINGNCT07317648ClearSight NextGen1 StudyCOMPLETED

Other records listing Becton, Dickinson and Company 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.

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeK260184Onclarity™ Self-Collection KitK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesK2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe

View all 100 devices →

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.K252506BD 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 TechnologiesK243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company

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.

↑