Savina 300
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Savina 300 EUDAMED
- Model / Reference
- 411628 EUDAMED8417801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675411628 EUDAMED
- Basic UDI-DI
- B-04048675411628 EUDAMED
- 510(k) Number
- K180779 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
Yes
Incorporates Medicinal Product
No
The Savina 300 is a continuous-use ventilator designed for facility-based settings. As classified under FDA device type Ventilator, it provides mechanical respiratory support by delivering controlled ventilation to patients requiring assisted or fully controlled breathing, typically in critical care or perioperative environments. Its functionality aligns with the Continuous category, ensuring sustained respiratory assistance for extended periods.
This device is intended for facility use and is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD). The Savina 300 is supplied as a reusable medical device, requiring proper sterilization and maintenance protocols as outlined by the manufacturer. It is classified as Class II under FDA regulations and adheres to MRI safety standards as specified in 21 CFR 868.5895. Multiple FEI numbers and registration numbers confirm its compliance across various administrative classifications, including Anesthesiology as the primary medical specialty.
Frequently asked questions
What types of clinical settings is the Savina 300 intended for, and why is it classified as a facility-use device?
The Savina 300 is designed for facility-based settings, such as hospitals, surgical centers, or intensive care units, where continuous mechanical ventilation is required. It is classified as a facility-use device because it is intended for extended, controlled respiratory support in critical care or perioperative environments, where trained personnel and infrastructure are available to manage its operation and maintenance. This classification aligns with its role in providing sustained ventilation for patients requiring assisted or fully controlled breathing.
Is the Savina 300 a single-use or reusable device, and what maintenance or sterilization steps are required?
The Savina 300 is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and sterilization. Since it is not disposable, it must adhere to strict manufacturer-provided protocols for maintenance and sterilization to ensure patient safety and device functionality. These protocols typically include cleaning, sterilization (e.g., autoclave or chemical sterilization), and regular inspections to maintain performance and compliance with regulatory standards.
What regulatory pathways has the Savina 300 followed, and how does this impact its use in clinical environments?
The Savina 300 has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD), confirming its substantial equivalence to prior-generation ventilators. This regulatory route ensures the device meets safety, performance, and effectiveness standards for mechanical ventilation in facility settings. Clinically, this means it can be trusted for continuous-use scenarios in critical care, perioperative, or anesthesia environments where rigorous regulatory oversight is required.
Does the Savina 300 have any specific safety considerations, such as compatibility with MRI environments?
Yes, the Savina 300 adheres to MRI safety standards as specified in 21 CFR 868.5895, meaning it is designed to be safe for use in MRI environments when appropriate protocols are followed. This is particularly relevant in clinical settings where patients may require both ventilatory support and MRI imaging, ensuring the device does not interfere with MRI operations or pose risks to patients during scans.
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: PDF Focused on essentials DRÄGER SAVINA® 300 CLASSIC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180779 | Class II | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
- FDA Applicant
- Dragerwerk AG & CO Kgaa
Sources (2)
- FDA 510(k) K180779 24 fields · synced Oct 6, 2026
- EUDAMED 7553f7c8-a2ba-411d-9b67-db26b7ba76cc 61 fields · synced Jul 11, 2026