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FDA 510(k)

Steripath Gen2 Blood Collection System

K-Number: K192247 · 2020-02-28

ApplicantMagnolia Medical Technologies, Inc.
Decision Date2020-02-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Steripath Gen2 Blood Collection System is a medical device manufactured by Magnolia Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-02-28 under approval number K192247. 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 Gen2 Blood Collection System?

Steripath Gen2 Blood Collection System is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Magnolia Medical Technologies, Inc.. The 510(k) number is K192247.

When was Steripath Gen2 Blood Collection System approved by the FDA?

Steripath Gen2 Blood Collection System received FDA 510(k) clearance on 2020-02-28, under approval number K192247.

What company makes Steripath Gen2 Blood Collection System?

Steripath Gen2 Blood Collection System is manufactured by Magnolia Medical Technologies, Inc..

What is the FDA product code for Steripath Gen2 Blood Collection System?

The FDA product code for Steripath Gen2 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, Inc.

K200661Steripath 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.

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