Sechrist Infant Ventilator Model IV-100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K811141 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
- SESE Substantially Equivalent FDA 510(k)
The Sechrist Infant Ventilator Model IV-100 is a continuous-use ventilator designed for facility-based respiratory support in pediatric and neonatal patients. Classified as a Class II device, it delivers controlled mechanical ventilation to infants requiring assisted or full respiratory support, with adjustable parameters to meet varying clinical needs. Its microprocessor-based operation ensures precise control over ventilation settings, including pressure and flow rates, to optimize patient outcomes in critical care settings.
This ventilator is intended for facility use and has received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. Supplied as a reusable medical device, it requires proper cleaning, disinfection, and maintenance per manufacturer guidelines to ensure sterility and functionality. The device is not labeled for MRI compatibility and must be used in non-MRI environments. Authorized under regulation number 868.5895, it adheres to regulatory standards for ventilators in the United States.
Frequently asked questions
What is the Sechrist Infant Ventilator Model IV-100 used for?
The Sechrist Infant Ventilator Model IV-100 is designed for facility-based respiratory support in pediatric and neonatal patients. It provides controlled mechanical ventilation for infants requiring assisted or full respiratory support, allowing clinicians to adjust pressure and flow rates to meet individual patient needs in critical care environments.
How is the Sechrist Infant Ventilator Model IV-100 supplied and maintained?
This ventilator is supplied as a reusable medical device. To ensure proper functionality and sterility, it must be cleaned, disinfected, and maintained according to the manufacturer’s guidelines. Regular upkeep is essential for reliable performance in clinical settings.
Is the Sechrist Infant Ventilator Model IV-100 single-use or reusable?
The Sechrist Infant Ventilator Model IV-100 is explicitly designed as a reusable device. Unlike single-use ventilators, it requires proper cleaning, disinfection, and maintenance procedures to maintain its performance and sterility between patient use.
Can the Sechrist Infant Ventilator Model IV-100 be used in an MRI environment?
No, the Sechrist Infant Ventilator Model IV-100 is not labeled for MRI compatibility. It must only be used in non-MRI environments to avoid potential risks associated with magnetic fields.
What regulatory pathway was followed for the Sechrist Infant Ventilator Model IV-100?
The Sechrist Infant Ventilator Model IV-100 received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. This classification aligns with its use as a Class II medical device for facility-based respiratory support.
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 IV-100B Infant & Pediatric Ventilator - Soma Tech Intl, PDF Sechrist IV 100B - Ventilator - Soma Tech Intl, Sechrist Industries Inc | Resuscitation ventilator / infant Sechrist IV ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811141 | Class II | Active |
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Manufacturer
- Manufacturer
- Sechrist Industries Inc
- FDA Applicant
- Sechrist Industries, Inc.
Sources (1)
- FDA 510(k) K811141 24 fields · synced Oct 1, 2026