FDA product code BSZ: Gas-Machine, Anesthesia
BSZ is the FDA product code for gas-machine, anesthesia. It is a Class II device, regulated under 21 CFR 868.5160 and reviewed by the Anesthesiology panel. FDA has cleared 189 510(k) submissions under BSZ, 5 in the last five years, from 72 different applicants. The average 510(k) review took 147 days (median 111); 169 days on average over the last three years. FDA has posted 177 recalls for BSZ devices, 67 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gas-Machine, Anesthesia |
| Device class | Class II |
| Regulation | 21 CFR 868.5160 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for BSZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 217 |
| 2018 | 2 | 255 |
| 2020 | 1 | 335 |
| 2021 | 1 | 255 |
| 2023 | 2 | 292 |
| 2025 | 1 | 72 |
| 2026 | 2 | 266 |
Compare with all 510(k) review times · Search every BSZ clearance
Top BSZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Draeger Medical, Inc. | 33 | 2004-11-26 |
| Datex-Ohmeda, Inc. | 20 | 2023-03-28 |
| Ohmeda Medical | 17 | 1998-04-21 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 6 | 2026-06-25 |
| Maquet Critical Care AB | 5 | 2020-03-18 |
67 more applicants have BSZ clearances. See the full list in Caduvo.
Most recent BSZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253330 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | 2026-06-25 | 268 |
| K252746 | Drägerwerk AG Co. Kgaa | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | 2026-05-21 | 265 |
| K251352 | Codonics.Incorporated | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | 2025-07-11 | 72 |
| K230931 | Drägerwerk AG Co. Kgaa | Atlan | 2023-07-23 | 111 |
| K213867 | Datex-Ohmeda, Inc. | Carestation 750/750c | 2023-03-28 | 473 |
Recalls for BSZ devices
177 product recalls in 90 recall events; 67 initiated in the last five years and 74 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 8 |
| 2018 | 15 |
| 2019 | 5 |
| 2020 | 7 |
| 2021 | 5 |
| 2022 | 10 |
| 2023 | 6 |
| 2024 | 19 |
| 2025 | 23 |
| 2026 | 7 |
Frequently asked questions
What is FDA product code BSZ?
BSZ is the FDA product code for gas-machine, anesthesia. It is a Class II device, regulated under 21 CFR 868.5160 and reviewed by the Anesthesiology panel.
What device class is BSZ?
Class II, regulation 21 CFR 868.5160. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSZ?
Across 189 cleared submissions the average was 147 days from receipt to decision (median 111).
Which companies have the most BSZ clearances?
Draeger Medical, Inc. (33); Datex-Ohmeda, Inc. (20); Ohmeda Medical (17); Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (6); Maquet Critical Care AB (5).
Have BSZ devices been recalled?
Yes: 177 product recalls across 90 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code BSZ
- Run a recall and safety report across every BSZ manufacturer
- Watch product code BSZ 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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