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FDA 510(k)

LifeFlow Rapid Infusion Device (LifeFlow Device)

K-Number: K153731 · 2016-08-25

Applicant410 Medical Innovation, LLC
Decision Date2016-08-25
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LifeFlow Rapid Infusion Device (LifeFlow Device) is a medical device manufactured by 410 Medical Innovation, LLC. It received FDA 510(k) clearance on 2016-08-25 under approval number K153731. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeFlow Rapid Infusion Device (LifeFlow Device)?

LifeFlow Rapid Infusion Device (LifeFlow Device) is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by 410 Medical Innovation, LLC. The 510(k) number is K153731.

When was LifeFlow Rapid Infusion Device (LifeFlow Device) approved by the FDA?

LifeFlow Rapid Infusion Device (LifeFlow Device) received FDA 510(k) clearance on 2016-08-25, under approval number K153731.

What company makes LifeFlow Rapid Infusion Device (LifeFlow Device)?

LifeFlow Rapid Infusion Device (LifeFlow Device) is manufactured by 410 Medical Innovation, LLC.

What is the FDA product code for LifeFlow Rapid Infusion Device (LifeFlow Device)?

The FDA product code for LifeFlow Rapid Infusion Device (LifeFlow Device) is FPA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40906998 Recalls of Arthroscopic Equipment After Food and Drug Administration 510(k) Approval: A Twenty-Year Analysis of Causes, Trends, and Time to Recall (2004 to 2024). The Journal of the American Academy of Orthopaedic Surgeons (2026)

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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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