BZR — Mixer, Breathing Gases, Anesthesia Inhalation Class II
FDA product code BZR covers "Mixer, Breathing Gases, Anesthesia Inhalation", a Class II medical device regulated under 21 CFR 868.5330. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BZR
- Device Class
- Class II
- Regulation Number
- 868.5330
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243917 | fisher and paykel healthcare | F&P Optiflow Air/Oxygen Flow Source | July 14, 2025 |
| K241465 | parker hannifin corporation | Midas Flowmeter; eAVS | September 19, 2024 |
| K231895 | maxtec | Maxtec MaxBlend2+p | December 4, 2023 |
| K230987 | baldus sedation gmbh and co. kg | FlowStar Analog Mixer Flowmeter | September 14, 2023 |
| K222794 | baldus sedation gmbh and co. kg | FlowStar Touch Digital Mixer Flowmeter | July 28, 2023 |
| K221494 | dehas medical systems | Quality Mix Blender, Oxymixer | January 23, 2023 |
| K202480 | parker hannifin | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | April 22, 2021 |
| K173205 | o-two medical technologies | Equinox Advantage | August 29, 2018 |
| K161718 | maxtec | MaxBlend 2, MaxBlend Lite | October 27, 2016 |
| K142291 | gentec (shanghai) corporation | GMX Series Medical Air/Oxygen Blender | May 19, 2015 |
| K113687 | o-two medical technologies | EQUINOX RELIEVE | April 30, 2012 |
| K113232 | maxtec | MAXMIXING BLOCK | March 1, 2012 |
| K101286 | linde healthcare | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | October 20, 2011 |
| K103317 | atom medical corporation | RESUSCITATION UNIT 105 | April 20, 2011 |
| K092484 | cardinal health 207 | HELIOX LOW FLOW SENTRY BLENDER | April 2, 2010 |
| K090781 | precision medical | HELIO2 BLENDER | August 13, 2009 |
| K081335 | tenacore holdings | TENACORE OXYGEN BLENDER, MODEL TB-2000 | November 14, 2008 |
| K053232 | precision medical | PRECISION BLENDER | January 10, 2006 |
| K051192 | praxair | PRAXAIR MEDICAL AIR MIXER | September 6, 2005 |
| K050381 | cs medical | CS MEDICAL TTCF GAS DELIVERY SYSTEM | July 13, 2005 |