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Millennium Infant Ventilator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993167

by Sechrist Industries Inc

Identifiers

510(k) Number
K993167 FDA 510(k)
FDA Product Code
CBK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5895 FDA 510(k)
Regulation Number
868.5895 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
ST FDA 510(k)

The Millennium Infant Ventilator is a continuous-use medical device classified as a ventilator, designed specifically for neonatal and pediatric patients. It provides mechanical ventilation by delivering controlled breaths to support respiratory function in infants and young children, ensuring adequate oxygenation and ventilation in critical care settings. The device is engineered to deliver precise gas flow, pressure, and volume settings tailored to the patient’s needs, with features supporting both invasive and non-invasive ventilation modes.

This ventilator is intended for facility use and is supplied as a reusable device, requiring proper sterilization and maintenance between patient use. It is not MRI-safe and must be used in environments where magnetic resonance imaging is not performed. The device is authorized under FDA 510(k) clearance (K993167) and falls under regulatory classification 2, adhering to the requirements outlined in 21 CFR 868.5895. It is distributed by Sechrist Industries Inc., Anaheim, CA, and is tracked under the product code CBK.

Frequently asked questions

What is the Millennium Infant Ventilator used for?

The Millennium Infant Ventilator is designed specifically for neonatal and pediatric patients to provide mechanical ventilation. It delivers controlled breaths to support respiratory function, ensuring proper oxygenation and ventilation in critical care settings. The device is engineered to tailor gas flow, pressure, and volume settings to individual patient needs, accommodating both invasive and non-invasive ventilation modes.

How is the Millennium Infant Ventilator supplied and prepared for use?

The Millennium Infant Ventilator is a reusable device intended for facility use. Between patient uses, it must undergo proper sterilization and maintenance to ensure safety and functionality. This design ensures long-term reliability in clinical environments where multiple patients may require ventilation support.

Is the Millennium Infant Ventilator single-use or reusable?

The Millennium Infant Ventilator is a reusable device. Its design allows for repeated use in a clinical setting, provided it undergoes thorough sterilization and maintenance between patients. This approach supports cost-effective and sustainable ventilation solutions in neonatal and pediatric care.

Can the Millennium Infant Ventilator be used in an MRI environment?

No, the Millennium Infant Ventilator is not MRI-safe. It must be used in environments where magnetic resonance imaging is not performed, as exposure to MRI fields could pose risks to the device or interfere with its operation.

What regulatory approval does the Millennium Infant Ventilator hold?

The Millennium Infant Ventilator holds FDA 510(k) clearance under the reference number K993167. It is classified as a Class II device under 21 CFR 868.5895, adhering to regulatory requirements for continuous-use ventilators in neonatal and pediatric settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sechrist - Millennium Community, Manuals and Specifications | MedWrench, Sechrist Millennium Ventilator Manual, Millennium Infant Ventilator Manual | PDF | Chemical Engineering ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sechrist Industries Inc
FDA Applicant
Sechrist Industries, Inc.

Sources (1)

  • FDA 510(k) K993167 24 fields · synced Oct 1, 2026