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FDA 510(k)

ZIEN IO Intraosseous Access System

K-Number: K240915 · 2024-07-02

ApplicantZien Medical Technologies, Inc.
Decision Date2024-07-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZIEN IO Intraosseous Access System is a medical device manufactured by Zien Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-07-02 under approval number K240915. 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 ZIEN IO Intraosseous Access System?

ZIEN IO Intraosseous Access System is a medical device that received FDA 510(k) clearance on 2024-07-02. It is manufactured by Zien Medical Technologies, Inc.. The 510(k) number is K240915.

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

ZIEN IO Intraosseous Access System received FDA 510(k) clearance on 2024-07-02, under approval number K240915.

What company makes ZIEN IO Intraosseous Access System?

ZIEN IO Intraosseous Access System is manufactured by Zien Medical Technologies, Inc..

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

The FDA product code for ZIEN 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)

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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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