Product code BSZ: 510(k) clearances and predicates
Product code BSZ covers A5 Anesthesia System (A5); A7 Anesthesia System (A7). FDA lists 189 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
189 clearances on file under product code BSZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 2 |
| 2024 | 0 |
| 2025 | 1 |
| 2026 so far | 2 |
Recent clearances
Newest BSZ clearances in the FDA index, with applicant and decision date:
- K253330, A5 Anesthesia System (A5); A7 Anesthesia System (A7), applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd., decided 2026-06-25. FDA record
- K252746, Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL), applicant Drägerwerk AG Co. Kgaa, decided 2026-05-21. FDA record
- K251352, 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), applicant Codonics.Incorporated, decided 2025-07-11. FDA record
- K230931, Atlan, applicant Drägerwerk AG Co. Kgaa, decided 2023-07-23. FDA record
- K213867, Carestation 750/750c, applicant Datex-Ohmeda, Inc., decided 2023-03-28. FDA record
- K201957, A8, A9 Anesthesia System, applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd., decided 2021-03-26. FDA record
- K191027, Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System, applicant Maquet Critical Care AB, decided 2020-03-18. FDA record
- K171311, A5 Anesthesia System, applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd., decided 2018-01-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL), 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). Watch new BSZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code BSZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent BSZ clearances include A5 Anesthesia System (A5); A7 Anesthesia System (A7).
How many 510(k) clearances use product code BSZ?
189 at the time this page was generated, from openFDA records.
How do I find a predicate device under BSZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new BSZ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.