Vaporizer, Anesthesia, Non-Heated
FDA product code CAD · Class II (moderate risk) · 21 CFR 868.5880 · Anesthesiology
57510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Penlon, Inc. 9
- Draeger Medical, Inc. 7
- Datex-Ohmeda, Inc. 6
- Southmedic, Inc. 5
- Ohmeda Medical 3
- Technimeca Medic, Inc. 2
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 2
- Ohio Medical Products 2
- Fraser Harlake, Inc. 1
- Siemens Elema AB 1
- Siemens Corp. 1
- Promed Corp. 1
- Rusz Instruments, Inc. 1
- Bear Medical Systems, Inc. 1
- Mayfield Instruments, Ltd. 1
- Air Products & Chemicals, Inc. 1
- Vaporflow Technology, Inc. 1
- Dentsply Intl. 1
- Precept, Inc. 1
- Cyprane North America, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240375 | V80 Anesthetic Vaporizer (V80)CAD · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/31/2024SE |
| K172702 | Tec 820, Tec 850CAD · Traditional | Datex-Ohmeda, Inc. | 01/04/2018SE |
| K150167 | V60 Anesthetic VaporizerCAD · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/30/2015SE |
| K110608 | Sevoflurane Vaporizer AdaptorCAD · Traditional | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 07/20/2011SE |
| K060331 | Sigma Alpha VaporizerCAD · Traditional | Penlon Limited | 05/10/2006SE |
| K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454CAD · Traditional | Penlon Limited | 03/03/2006SE |
| K051666 | Gav - General Anaesthetic VaporizerCAD · Traditional | General Anaesthetic Services Limited | 08/23/2005SE |
| K042276 | D-VaporCAD · Traditional | Draeger Medical, Inc. | 09/23/2004SE |
| K041076 | Delta TCAD · Special | Penlon , Ltd. | 08/09/2004SE |
| K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)CAD · Special | Datex-Ohmeda, Inc. | 06/26/2003SE |
| K012924 | Datex-Ohmeda Tec 7 Anesthesia VaporizerCAD · Special | Datex-Ohmeda, Inc. | 01/30/2002SE |
| K002343 | Sigma DeltaCAD · Traditional | Penlon , Ltd. | 06/08/2001SE |
| K002878 | Datex-Ohmeda D-Tec Plus Anesthesia VaporizerCAD · Special | Datex-Ohmeda, Inc. | 09/21/2000SE |
| K000275 | Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant…CAD · Special | Datex-Ohmeda, Inc. | 04/12/2000SE |
| K990132 | Datex-Ohmeda Anesthesia Vaporizer, Model D-TecCAD · Special | Datex-Ohmeda, Inc. | 01/21/1999SE |
| K980489 | Vapamasta 6CAD · Traditional | Medical Industrial Equipment | 08/31/1998SE |
| K980884 | Siemens Sevoflurane Vaporizer SV 953CAD · Traditional | Siemens Medical Solutions USA, Inc. | 08/19/1998SE |
| K981773 | Drager-Vapor 19.3CAD · Traditional | Draeger Medical, Inc. | 07/06/1998SE |
| K981472 | Drager-Vapor 19.1 W/Plug System S PlusCAD · Special | Draeger Medical, Inc. | 05/07/1998SE |
| K973051 | Drager-Vapor 19.1 W/Plug System S PlusCAD · Traditional | Draeger Medical, Inc. | 10/30/1997SE |
| K971923 | Drager-Vapor 2000CAD · Traditional | Draeger Medical, Inc. | 09/16/1997SE |
| K952083 | Tec IV and Tec V Anesthesia Vaporizers for SevofluraneCAD · Traditional | Clover Medical Equipment Services, Inc. | 10/21/1996SE |
| K961468 | Quik-Fil Vaporizer Keyed FillerCAD · Traditional | Penlon , Ltd. | 07/16/1996SE |
| K960944 | PPV Vaporizer (Modification)CAD · Traditional | Penlon , Ltd. | 04/02/1996SE |
| K954801 | TechfilCAD · Traditional | Technimeca Medic, Inc. | 01/25/1996SE |
| K953748 | TechnofilCAD · Traditional | Technimeca Medic, Inc. | 01/25/1996SE |
| K942799 | DatumCAD · Traditional | Blease USA, Inc. | 04/13/1995SE |
| K942091 | Ohmeda Tec 5 Vaporizer for Use with SevofluraneCAD · Traditional | Ohmeda Medical | 03/30/1995SE |
| K945993 | VapofilCAD · Traditional | Southmedic, Inc. | 02/22/1995SE |
| K942545 | Sigma EliteCAD · Traditional | Penlon , Ltd. | 02/03/1995SE |
| K942055 | Drager-Vapor 19.1CAD · Traditional | North American Grager | 01/27/1995SE |
| K936046 | Sigma EliteCAD · Traditional | Penlon, Inc. | 11/04/1994SE |
| K923265 | Funnel AdaptorCAD · Traditional | Southmedic, Inc. | 03/18/1993SE |
| K913593 | Ohmeda Tec 6 Continuous Flow VaporizerCAD · Traditional | Ohmeda Medical | 10/06/1992SE |
| K892057 | Ohmeda Tec 5 Continuous Flow VaporizerCAD · Traditional | Ohmeda Medical | 04/26/1989SE |
| K884686 | Vapamasta 5CAD · Traditional | Dentsply Intl. | 03/15/1989SE |
| K884090 | Lundy Vaporizer SystemCAD · Traditional | Vaporflow Technology, Inc. | 01/24/1989SE |
| K882500 | Vaporizer, Anesthesia, Non-HeatedCAD · Traditional | Anesthetic Vaporizer Services | 08/01/1988SE |
| K872053 | KeyfillCAD · Traditional | Mayfield Instruments, Ltd. | 07/01/1987SE |
| K864605 | VaplokCAD · Traditional | Bear Medical Systems, Inc. | 02/03/1987SE |
| K861839 | VapofilCAD · Traditional | Southmedic, Inc. | 05/21/1986SE |
| K860545 | Vaporizer SpacerCAD · Traditional | Southmedic, Inc. | 04/17/1986SE |
| K854202 | Anesthesia Ventilator Model 100CAD · Traditional | Rusz Instruments, Inc. | 04/11/1986SE |
| K844007 | Penlon PPV VaporizerCAD · Traditional | Penlon, Inc. | 03/12/1985SE |
| K843993 | Anaeslock Three Vaporizer Interlock HVA003CAD · Traditional | Southmedic, Inc. | 11/15/1984SE |
| K841157 | Halothane Vaporizer 950, EnfluraneCAD · Traditional | Siemens Elema AB | 06/07/1984SE |
| K831427 | Cyprane Tec 4 Continuous Flow Vapor.CAD · Traditional | Fraser Harlake, Inc. | 07/07/1983SE |
| K821966 | Modulus Verni-Trol Anesthetic VaporizerCAD · Traditional | Ohio Medical Products | 07/16/1982SE |
| K821650 | Drager Vapor 19.1 Anesthetic VaporizersCAD · Traditional | Draeger Medical, Inc. | 06/29/1982SE |
| K810289 | Modulus Verni-Trol Anesthetic VaporizerCAD · Traditional | Ohio Medical Products | 03/04/1981SE |
| K790359 | Halothane Vaporizer 950, & Enflurane 951CAD · Traditional | Siemens Corp. | 03/21/1979SE |
| K771892 | Valve AnestheticCAD · Traditional | Promed Corp. | 02/02/1978SE |
| K771899 | Vapor 19CAD · Traditional | Draeger Medical, Inc. | 10/18/1977SE |
| K771150 | Copper Kettle Vaporizer PlusCAD · Traditional | Air Products & Chemicals, Inc. | 08/04/1977SE |
| K770021 | Mask, Face, SurgicalCAD · Traditional | Precept, Inc. | 01/17/1977SE |
| K761160 | Model CNA-1 VaporizerCAD · Traditional | Cyprane North America, Inc. | 12/09/1976SE |
| K760668 | Selectatec SystemCAD · Traditional | Medishield, Inc. | 09/27/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0934-2026 Class I | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities. | Draeger, Inc. | 11/24/2025Open, Classified |
| Z-0933-2026 Class I | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities. | Draeger, Inc. | 11/24/2025Open, Classified |
| Z-0818-2025 Class II | Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEVDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | GE Medical Systems, LLC | 11/18/2024Open, Classified |
| Z-0817-2025 Class II | Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISODue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | GE Medical Systems, LLC | 11/18/2024Open, Classified |
| Z-0816-2025 Class II | Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEVDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | GE Medical Systems, LLC | 11/18/2024Open, Classified |
| Z-0815-2025 Class II | Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISODue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | GE Medical Systems, LLC | 11/18/2024Open, Classified |
| Z-0814-2025 Class II | Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000…Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic… | GE Medical Systems, LLC | 11/18/2024Open, Classified |
| Z-1198-2018 Class II | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific…Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be… | GE Healthcare, LLC | 10/04/2017Terminated |
| Z-1812-2016 Class II | Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles.…Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye… | Draeger Medical, Inc. | 04/21/2016Terminated |
| Z-1653-2013 Class II | Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic…It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the… | Penlon, Ltd. | 05/14/2013Terminated |
| Z-0201-2007 | Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which…There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6… | Datex - Ohmeda, Inc | 09/15/2006Terminated |