Savina 300

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Savina 300 Savina 300, Country Variants

510(k) Number

K121886 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Draeger Medical, Inc. →

• What is the Savina 300 ventilator intended for?

  The Savina 300 is a continuous ventilator designed for facility use in anesthesiology settings, as indicated by its product code CBK and medical specialty description of Anesthesiology in the authorization documentation.

• Is the Savina 300 a single-use or reusable device?

  The Savina 300 is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between patients, as stated in the device description.

• What regulatory pathway was used for the Savina 300's market authorization?

  The Savina 300 received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device, as indicated by the authorization type FDA_510K and clearance_type Traditional.

• What classifies the Savina 300 under FDA regulations?

  The Savina 300 is classified as a Class II medical device under product code CBK, which corresponds to continuous ventilators for facility use, as specified in the openfda device_class field and product_code.

• Are there different versions of the Savina 300 available for different countries?

  Yes, the Savina 300 is supplied with country variants as specified in the authorization documentation, meaning configurations may differ based on regional requirements while maintaining the same core device functionality.