FDA product code BZR: Mixer, Breathing Gases, Anesthesia Inhalation
BZR is the FDA product code for mixer, breathing gases, anesthesia inhalation. It is a Class II device, regulated under 21 CFR 868.5330 and reviewed by the Anesthesiology panel. FDA has cleared 55 510(k) submissions under BZR, 6 in the last five years, from 40 different applicants. The average 510(k) review took 142 days (median 120); 162 days on average over the last three years. FDA has posted 3 recalls for BZR devices.
Classification
| Field | Value |
|---|---|
| Device name | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class II |
| Regulation | 21 CFR 868.5330 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 331 |
| 2021 | 1 | 237 |
| 2023 | 4 | 220 |
| 2024 | 1 | 119 |
| 2025 | 1 | 206 |
Compare with all 510(k) review times · Search every BZR clearance
Top BZR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bird Products Corp. | 5 | 1998-05-07 |
| Sk Med | 4 | 2004-01-21 |
| Maxtec, LLC | 2 | 2023-12-04 |
| Baldus Sedation GmbH & Co. KG | 2 | 2023-09-14 |
| O-Two Medical Technologies, Inc. | 2 | 2018-08-29 |
35 more applicants have BZR clearances. See the full list in Caduvo.
Most recent BZR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243917 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Air/Oxygen Flow Source | 2025-07-14 | 206 |
| K241465 | Parker Hannifin Corporation | Midas Flowmeter; eAVS | 2024-09-19 | 119 |
| K231895 | Maxtec, LLC | Maxtec MaxBlend2+p | 2023-12-04 | 159 |
| K230987 | Baldus Sedation GmbH & Co. KG | FlowStar Analog Mixer Flowmeter | 2023-09-14 | 161 |
| K222794 | Baldus Sedation GmbH & Co. KG | FlowStar Touch Digital Mixer Flowmeter | 2023-07-28 | 315 |
Recalls for BZR devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-15.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code BZR?
BZR is the FDA product code for mixer, breathing gases, anesthesia inhalation. It is a Class II device, regulated under 21 CFR 868.5330 and reviewed by the Anesthesiology panel.
What device class is BZR?
Class II, regulation 21 CFR 868.5330. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZR?
Across 55 cleared submissions the average was 142 days from receipt to decision (median 120).
Which companies have the most BZR clearances?
Bird Products Corp. (5); Sk Med (4); Maxtec, LLC (2); Baldus Sedation GmbH & Co. KG (2); O-Two Medical Technologies, Inc. (2).
Have BZR devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2018-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code BZR
- Run a recall and safety report across every BZR manufacturer
- Watch product code BZR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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