Savina 300 Savina 300, Country Variants
FDA 510(k) K121886 · Draeger Medical GmbH
510(k) numberK121886
Submission
- Device name
- Savina 300 Savina 300, Country Variants
- Applicant
- Draeger Medical GmbH
Andover, MA, US - Received
- June 28, 2012
- Decision date
- August 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
| K252663 | Inbentus VersatileCBK · Traditional | Iconic Solutions by Murcia, SL | 04/14/2026SE |
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K133886 | Perseus A500BSZ · Traditional | 06/20/2014SE |
| K121999 | General Purpose Temperature Probe, Skin Temperature ProbeFLL · Traditional | 02/28/2013SE |
| K103035 | Smartpilot View Model MK04500BSZ · Traditional | 03/28/2012SE |
| K102618 | Ventstar Heated, Infinity Id Breathing Circuit HeatedBTT · Traditional | 12/10/2010SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | 08/06/2010SE |
| K100941 | Infinity Mcable - Mainstream CO2CCK · Special | 04/23/2010SE |
| K092999 | NBP CuffDXQ · Traditional | 11/24/2009SE |
| K083050 | Evite XLCBK · Special | 12/29/2008SE |
| K081447 | Fourth Gas Module with CO2 for Primus US ApolloBSZ · Traditional | 10/08/2008SE |
| K081743 | Classicstar NV Se and Novastar NV Se and Aav Full Face MasksCBK · Traditional | 09/22/2008SE |
Questions and answers
When was Savina 300 Savina 300, Country Variants cleared by the FDA?
Savina 300 Savina 300, Country Variants (K121886) received a 510(k) decision of Substantially Equivalent on August 8, 2014, 771 days after the submission was received.
What is the product code of K121886?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.