Data / Medical devices / Apparatus, Gas-Scavenging
Apparatus, Gas-Scavenging (CBN): 14 FDA-registered makers in 2 countries
14 establishments in 2 countries are registered with the FDA to make Apparatus, Gas-Scavenging (product code CBN, Class 2, 21 CFR 868.5430). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 43 510(k) clearances under this code, the latest on March 5, 2023, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- CBN
- Device class
- 2
- Regulation
- 868.5430
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Mexico | 3 |
Makers of Apparatus, Gas-Scavenging
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 |
|---|---|---|---|---|---|---|---|---|
| Precision Fluidics Division Parker Hannifin Corp. | Hatfield, PA, United States | Manufacturer | 3 | March 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Accutron, Inc. | Phoenix, AZ, United States | Manufacturer | 2 | March 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Carestream Medical | Sanford, FL, United States | Manufacturer | 2 | June 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | October 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Anecare LLC | Salt Lake City, UT, United States | Manufacturer, Specification developer | 1 | July 22, 2005 | 0 | 0 | 0 | api.fda.gov |
| Dynasthetics | Salt Lake City, UT, United States | Manufacturer | 1 | April 16, 2010 | 0 | 1 | 0 | api.fda.gov |
| Peace Medical, Inc. | Wharton, NJ, United States | Manufacturer | 1 | October 15, 1990 | 0 | 0 | 0 | api.fda.gov |
| Sedation Systems LLC | Tierra Verde, FL, United States | Specification developer | 1 | May 5, 2017 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | October 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Datex-Ohmeda, Inc. | Madison, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hda Technology, Inc. | Lake Forest, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 5, 2023. 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.