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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)
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Top companies in BSZ

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Datex-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
BSZK172045
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Open, Classified
BSZK172045
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Open, Classified
BSZK172045
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Open, Classified
BSZK172045
Aug 3, 2026Maquet 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
BSZK191027
Jun 4, 2026Draeger, Inc.
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Open, Classified
BSZK230931
Jun 4, 2026Draeger, Inc.
Atlan A350. Model Number: 8211500. anesthesia workstation
Open, Classified
BSZK230931
Dec 18, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Open, Classified
BSZK151570
K213867
Dec 18, 2025GE 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
BSZK213867
Dec 18, 2025GE 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
BSZK151570
Nov 26, 2025Mindray 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
BSZK201957
Nov 26, 2025Mindray 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
BSZK201957
Oct 1, 2025Draeger, 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
BSZK230931
Oct 1, 2025Draeger, 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
BSZK230931
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
Open, Classified
BSZK213867
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
Open, Classified
BSZK213867
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Open, Classified
BSZK151570
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Open, Classified
BSZK151570
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Open, Classified
BSZK151570
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
Open, Classified
BSZK151570
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
Open, Classified
BSZK151570
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Open, Classified
BSZNone listed
Apr 29, 2025GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Open, Classified
BSZK151570
Feb 7, 2025Getinge 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
BSZK191027
Dec 18, 2024Draeger 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
BSZK230931
Dec 18, 2024Draeger 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
BSZK230931
Nov 13, 2024Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Open, Classified
BSZK230931
Nov 13, 2024Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Open, Classified
BSZK230931
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Oct 18, 2024Datex-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
BSZK172045
Sep 4, 2024Mindray 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
BSZK201957
Sep 4, 2024Mindray 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
BSZK201957
Sep 4, 2024Mindray 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
BSZK201957
Sep 4, 2024Mindray 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
BSZK201957
May 31, 2024Getinge 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
BSZK191027
Apr 18, 2024Draeger Medical, Inc.
Drger Perseus A500 Anesthesia Workstation
Open, Classified
BSZK133886
Feb 6, 2024Getinge Usa Sales Inc
Flow-e Anesthesia System, model 6887900
Open, Classified
BSZK133958

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