Data / Medical devices / Vaporizer, Anesthesia, Non-Heated
Vaporizer, Anesthesia, Non-Heated (CAD): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Vaporizer, Anesthesia, Non-Heated (product code CAD, Class 2, 21 CFR 868.5880). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 57 510(k) clearances under this code, the latest on October 31, 2024, and lists 7 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- CAD
- Device class
- 2
- Regulation
- 868.5880
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 3 |
| China | 2 |
| Germany | 2 |
| Canada | 1 |
Makers of Vaporizer, Anesthesia, Non-Heated
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Madison, WI, United States | Manufacturer | 7 | January 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Repackager or relabeler, Specification developer | 4 | October 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 3 | June 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Penlon Ltd. | ABINGDON Oxfordshire, United Kingdom | Manufacturer | 3 | March 3, 2006 | 0 | 1 | 0 | api.fda.gov |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Manufacturer | 2 | September 23, 2004 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | October 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Southmedic, Inc. | BARRIE Ontario, Canada | Manufacturer | 1 | February 22, 1995 | 0 | 1 | 0 | api.fda.gov |
| Spacelabs Healthcare Ltd. | HERTFORD Hertfordshire, United Kingdom | Specification developer | 1 | April 13, 1995 | 0 | 0 | 0 | api.fda.gov |
| Automatics Tooling Company Ltd | Salfords Surrey, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piramal Critical Care, Inc. | Bethlehem, PA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 31, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.