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FDA 510(k)

BD Plastipak™ Syringe

K-Number: K251350 · 2025-07-29

ApplicantBecton, Dickinson and Company
Decision Date2025-07-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Plastipak™ Syringe 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 2025-07-29 under 510(k) number K251350. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Plastipak™ Syringe?

BD Plastipak™ Syringe is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K251350.

When did BD Plastipak™ Syringe receive FDA 510(k) clearance?

BD Plastipak™ Syringe received FDA 510(k) clearance on 2025-07-29, under 510(k) number K251350.

Who is the listed applicant for BD Plastipak™ Syringe?

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 Plastipak™ Syringe?

The FDA product code for BD Plastipak™ Syringe is FMF.

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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 PAPILLOMAVIRUSK260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesK252506BD 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 Tubes

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Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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