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FDA 510(k)

SAM IO Intraosseous Access System

K-Number: K191488 · 2019-11-21

ApplicantSam® Medical Products, Inc.
Decision Date2019-11-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAM IO Intraosseous Access System is a medical device manufactured by Sam® Medical Products, Inc.. It received FDA 510(k) clearance on 2019-11-21 under approval number K191488. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAM IO Intraosseous Access System?

SAM IO Intraosseous Access System is a medical device that received FDA 510(k) clearance on 2019-11-21. It is manufactured by Sam® Medical Products, Inc.. The 510(k) number is K191488.

When was SAM IO Intraosseous Access System approved by the FDA?

SAM IO Intraosseous Access System received FDA 510(k) clearance on 2019-11-21, under approval number K191488.

What company makes SAM IO Intraosseous Access System?

SAM IO Intraosseous Access System is manufactured by Sam® Medical Products, Inc..

What is the FDA product code for SAM IO Intraosseous Access System?

The FDA product code for SAM IO Intraosseous Access System is FMI.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 36476364 ScanMedicine: An online search system for medical innovation. Contemporary clinical trials (2023) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

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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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