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FDA 510(k)

Steripath® Flow™ Blood Collection System

K-Number: K251812 · 2025-09-25

ApplicantMagnolia Medical Technologies
Decision Date2025-09-25
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Steripath® Flow™ Blood Collection System is the device name listed in this FDA 510(k) record. The listed applicant is Magnolia Medical Technologies. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251812. 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 Steripath® Flow™ Blood Collection System?

Steripath® Flow™ Blood Collection System is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Magnolia Medical Technologies. The 510(k) number is K251812.

When did Steripath® Flow™ Blood Collection System receive FDA 510(k) clearance?

Steripath® Flow™ Blood Collection System received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251812.

Who is the listed applicant for Steripath® Flow™ Blood Collection System?

The FDA 510(k) record lists Magnolia Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steripath® Flow™ Blood Collection System?

The FDA product code for Steripath® Flow™ Blood Collection System is JKA.

Other records listing Magnolia Medical Technologies 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.

K222299Steripath Micro Blood Collection SystemK200661Steripath Micro Blood Collection SystemK192247Steripath Gen2 Blood Collection System

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 CompanyK243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company

Official Source

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

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