Identifiers
- 510(k) Number
- K131877 FDA 510(k)
- FDA Product Code
- BTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5925 FDA 510(k)
- Regulation Number
- 868.5925 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SAVE II and SAVE II Basic are powered, emergency ventilators designed for mechanical ventilation in critical care settings. Classified as Emergency Powered (Resuscitator) Ventilators, these devices provide automated, adjustable ventilation to support respiratory function in patients requiring assisted breathing, particularly in pre-hospital, aeromedical, or austere environments where traditional ventilators may not be feasible.
These ventilators are battery-powered, portable, and intended for single-use or reusable applications depending on manufacturer guidelines. The SAVE II Basic model is a simplified version of the SAVE II, offering essential ventilation functions without advanced features. Both devices are regulated under FDA 510(k) clearance (K131877) and fall under the Anesthesiology specialty category, adhering to Class II medical device standards (regulation number 868.5925). No third-party review or additional regulatory markings are indicated.
Frequently asked questions
What is the SAVE II ventilator designed for?
The SAVE II is a powered, emergency ventilator intended for mechanical ventilation in critical care environments where traditional ventilators are impractical. It provides automated, adjustable ventilation to support respiratory function in patients requiring assisted breathing, particularly in pre-hospital, aeromedical, or austere settings like remote or disaster areas. Its design prioritizes portability and battery operation to ensure functionality in environments lacking reliable power sources.
How is the SAVE II supplied, and can it be reused?
The SAVE II can be used either as a single-use device or as a reusable ventilator, depending on the manufacturer’s guidelines. The decision to reuse should follow established protocols for cleaning, disinfection, and maintenance to ensure patient safety and device performance. The manufacturer’s instructions should be consulted for specific reuse procedures, including sterilization methods if applicable.
What distinguishes the SAVE II Basic from the SAVE II?
The SAVE II Basic is a simplified version of the SAVE II, offering essential ventilation functions without the advanced features found in the full SAVE II model. While both devices share core capabilities for automated, adjustable ventilation, the Basic version omits additional functionalities that may be required in more complex clinical scenarios. This makes the Basic model suitable for environments where fewer features are necessary.
Are there different sizes or models of the SAVE II ventilator?
The SAVE II and SAVE II Basic are the primary models available, with no additional size variations explicitly mentioned in the provided data. Both models are designed as portable, battery-powered ventilators, but the Basic version is tailored for simpler ventilation needs. For specific configurations or accessories, refer to the manufacturer’s documentation or support resources.
How should the SAVE II ventilator be stored?
Storage instructions for the SAVE II ventilator are not detailed in the provided data, but general best practices for portable medical devices apply. The device should be stored in a clean, dry environment protected from extreme temperatures, direct sunlight, and physical damage. If the ventilator is reusable, follow manufacturer guidelines for maintenance and storage after use to preserve functionality and ensure readiness for emergency deployment.
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: Safeguard Medical | SAVe II+™ Simplified Automated Ventilator, SAVe II+ Simplified Automated Ventilator - Medical - MED-TAC, AutoMedx SAVe II Operating And Maintaining - ManualsLib, AUTOMEDX SAVE II OPERATION MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131877 | Class II | Active |
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Manufacturer
- Manufacturer
- Automedx, Inc.
Sources (1)
- FDA 510(k) K131877 24 fields · synced Oct 1, 2026