Panels › Anesthesiology › Product code BSZ · Class 2
Gas-Machine, Anesthesia
Regulation 868.5160
2510(k)s in 12 months (189 all time)
12recalls in 12 months (177 all time)
161recalls that name a 510(k)
Top companies in BSZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Datex-Ohmeda, Inc. Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 Open, Classified |
BSZ | K172045 |
| Aug 3, 2026 | Maquet Critical Care AB Flow Anesthesia Machine
Flow-i C20 6677200
Flow-i C30 6677300
Flow-i C40 6677400
Flow-i C20 6888520
Flow-i C30 6888530
Flow-i C40 6888540
Flow-c 6887700
Flow-e 6887900 Open, Classified |
BSZ | K191027 |
| Jun 4, 2026 | Draeger, Inc. Atlan A350XL. Model Number: 8621600. anesthesia workstation Open, Classified |
BSZ | K230931 |
| Jun 4, 2026 | Draeger, Inc. Atlan A350. Model Number: 8211500. anesthesia workstation Open, Classified |
BSZ | K230931 |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S Open, Classified |
BSZ | K151570 K213867 |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 750 A1, REF 1012-9750-000;
Carestation 750 A2, REF 1012-9750-002;
Carestation 750c A1, REF 1012-9755-000;
Open, Classified |
BSZ | K213867 |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 610 A1, REF 1012-9620-222;
Carestation 620 A1 REF 1012-9620-000;
Carestation 620 A1, REF 1012-9620-200;
C Open, Classified |
BSZ | K151570 |
| 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 | K201957 |
| 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 | K201957 |
| Oct 1, 2025 | Draeger, Inc. Brand Name: Atlan
Product Name: Atlan A350XL
Model/Catalog Number: 8621600
Software Version: Not Applicable
Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizin Open, Classified |
BSZ | K230931 |
| Oct 1, 2025 | Draeger, Inc. Brand Name: Atlan
Product Name: Atlan A350
Model/Catalog Number: 8211500
Software Version: Not applicable
Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing Open, Classified |
BSZ | K230931 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. Open, Classified |
BSZ | K213867 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. Open, Classified |
BSZ | K213867 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems Open, Classified |
BSZ | K151570 |
| Feb 7, 2025 | Getinge Usa Sales Inc Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia. Open, Classified |
BSZ | K191027 |
| Dec 18, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A300XL
Model/Catalog Number: 8621400
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Open, Classified |
BSZ | K230931 |
| Dec 18, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A300
Model/Catalog Number: 8211300
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Open, Classified |
BSZ | K230931 |
| Nov 13, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A350XL
Model/Catalog Number: 8621600
Software Version: Not Applicable
Component: Not applicable Open, Classified |
BSZ | K230931 |
| Nov 13, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A350
Model/Catalog Number: 8211500
Software Version: Not applicable
Component: Not applicable Open, Classified |
BSZ | K230931 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified i Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in th Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in t Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and a Open, Classified |
BSZ | K172045 |
| 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 | K201957 |
| 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 | K201957 |
| 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 | K201957 |
| 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 | K201957 |
| May 31, 2024 | Getinge Usa Sales Inc Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e. Open, Classified |
BSZ | K191027 |
| Apr 18, 2024 | Draeger Medical, Inc. Drger Perseus A500 Anesthesia Workstation Open, Classified |
BSZ | K133886 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-e Anesthesia System, model 6887900 Open, Classified |
BSZ | K133958 |
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