FlowStar Analog Mixer Flowmeter
FDA 510(k) K230987 · Baldus Sedation GmbH & Co. KG
510(k) numberK230987
Submission
- Device name
- FlowStar Analog Mixer Flowmeter
- Applicant
- Baldus Sedation GmbH & Co. KG
Bendorf, DE - Received
- April 6, 2023
- Decision date
- September 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZR – Mixer, Breathing Gases, Anesthesia Inhalation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5330
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | Fisher & Paykel Healthcare, Ltd. | 07/14/2025SE |
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | Parker Hannifin Corporation | 09/19/2024SE |
| K231895 | Maxtec MaxBlend2+pBZR · Traditional | Maxtec, LLC | 12/04/2023SE |
| K222794 | FlowStar Touch Digital Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 07/28/2023SE |
| K221494 | Quality Mix Blender, OxymixerBZR · Traditional | Dehas Medical Systems GmbH | 01/23/2023SE |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | Parker Hannifin | 04/22/2021SE |
| K173205 | Equinox AdvantageBZR · Traditional | O-Two Medical Technologies, Inc. | 08/29/2018SE |
| K161718 | MaxBlend 2, MaxBlend LiteBZR · Traditional | Maxtec, LLC | 10/27/2016SE |
| K142291 | GMX Series Medical Air/Oxygen BlenderBZR · Traditional | Gentec (Shanghai) Corporation | 05/19/2015SE |
| K113687 | Equinox RelieveBZR · Traditional | O-Two Medical Technologies, Inc. | 04/30/2012SE |
More from O-Two Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222794 | FlowStar Touch Digital Mixer FlowmeterBZR · Traditional | 07/28/2023SE |
Questions and answers
When was FlowStar Analog Mixer Flowmeter cleared by the FDA?
FlowStar Analog Mixer Flowmeter (K230987) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 161 days after the submission was received.
What is the product code of K230987?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.