Panels › Anesthesiology › Product code CAD · Class 2
Vaporizer, Anesthesia, Non-Heated
Regulation 868.5880
0510(k)s in 12 months (57 all time)
2recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in CAD
| Company | 510(k)s | Recalls |
|---|---|---|
| Penlon , Ltd. | 9 | 1 |
| Draeger Medical, Inc. | 7 | 1 |
| Datex-Ohmeda, Inc. | 6 | 1 |
| Southmedic, Inc. | 5 | 2 |
| GE Medical Systems, LLC | 0 | 5 |
| Ohmeda Medical | 3 | 0 |
| Draeger, Inc. | 0 | 2 |
| Ohio Medical Products | 2 | 0 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2 | 0 |
| Technimeca Medic, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2025 | Draeger, Inc. Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. Open, Classified |
CAD | K971923 |
| Dec 23, 2025 | Draeger, Inc. Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. Open, Classified |
CAD | K971923 |
| Jan 7, 2025 | GE Medical Systems, LLC Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV Open, Classified |
CAD | K172702 |
| Jan 7, 2025 | GE Medical Systems, LLC Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO Open, Classified |
CAD | K172702 |
| Jan 7, 2025 | GE Medical Systems, LLC Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV Open, Classified |
CAD | K172702 |
| Jan 7, 2025 | GE Medical Systems, LLC Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO Open, Classified |
CAD | K172702 |
| Jan 7, 2025 | GE Medical Systems, LLC Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 207 Open, Classified |
CAD | K000275 |
| Oct 4, 2017 | GE Healthcare, LLC DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. Terminated |
CAD | K012924 |
| Apr 21, 2016 | Draeger Medical, Inc. Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer Terminated |
CAD | K042276 |
| Jul 2, 2013 | Penlon, Ltd. Delta Vaporizer
An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient. Terminated |
CAD | K002343 |
| Nov 21, 2006 | Datex - Ohmeda, Inc Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane. Terminated |
CAD | K000275 |
| Jul 4, 2006 | Southmedic Inc Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. Terminated |
CAD | K945993 |
| Jul 4, 2006 | Southmedic Inc Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. Terminated |
CAD | K945993 |
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