FDA 510(k)

Steripath® Flow Blood Collection System

K-Number: K251812 · 2025-09-25

Decision Date2025-09-25

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Steripath® Flow Blood Collection System is a medical device manufactured by Magnolia Medical Technologies. It received FDA 510(k) clearance on 2025-09-25 under approval 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. It is manufactured by Magnolia Medical Technologies. The 510(k) number is K251812.

When was Steripath® Flow Blood Collection System approved by the FDA?

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

What company makes Steripath® Flow Blood Collection System?

Steripath® Flow Blood Collection System is manufactured by Magnolia Medical Technologies.

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

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

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Magnolia Medical Technologies

K222299Steripath Micro Blood Collection System

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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.