FlowStar Touch Digital Mixer Flowmeter
FDA 510(k) clearance K222794 · decided 2023-07-28
Clearance details
- K-number
- K222794
- Device name
- FlowStar Touch Digital Mixer Flowmeter
- Applicant
- Baldus Sedation GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2022-09-16
- Decision date
- 2023-07-28
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- BZR
- Device class
- 2
- Regulation number
- 868.5330
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bendorf, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| F&P Optiflow Air/Oxygen Flow Source (K243917) | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
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| Maxtec MaxBlend2+p (K231895) | Maxtec, LLC | 2023-12-04 |
| FlowStar Analog Mixer Flowmeter (K230987) | Baldus Sedation GmbH & Co. KG | 2023-09-14 |
| Quality Mix Blender, Oxymixer (K221494) | Dehas Medical Systems GmbH | 2023-01-23 |
| Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (K202480) | Parker Hannifin | 2021-04-22 |
| Equinox Advantage (K173205) | O-Two Medical Technologies, Inc. | 2018-08-29 |
| MaxBlend 2, MaxBlend Lite (K161718) | Maxtec, LLC | 2016-10-27 |
| GMX Series Medical Air/Oxygen Blender (K142291) | Gentec (Shanghai) Corporation | 2015-05-19 |
| EQUINOX RELIEVE (K113687) | O-Two Medical Technologies, Inc. | 2012-04-30 |
| MAXMIXING BLOCK (K113232) | Maxtec, Inc. | 2012-03-01 |
| SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 (K101286) | Linde Healthcare AB | 2011-10-20 |
Recalls involving this device
No recalls on record reference this clearance.