510(k) K201957 ยท BSZ Gas-Machine, Anesthesia
A8, A9 Anesthesia System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 26, 2021 |
| Received | Jul 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | Mindray DS USA, Inc. dba Mindray North America Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:
1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.
2. Exchange Sev E_Vap. (Safe Open, Classified |
BSZ | None listed |
| Nov 26, 2025 | Mindray DS USA, Inc. dba Mindray North America Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:
1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00.
2. Exchange Iso E_Vap. (Safety Open, Classified |
BSZ | None listed |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number 115-066755-00 Open, Classified |
BSZ | None listed |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Open, Classified |
BSZ | None listed |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Open, Classified |
BSZ | None listed |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Part Number1 Open, Classified |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.