Data / Medical devices / Conserver, Oxygen
Conserver, Oxygen (NFB): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Conserver, Oxygen (product code NFB, Class 2, 21 CFR 868.5905). 12 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 71 510(k) clearances under this code, the latest on July 24, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NFB
- Device class
- 2
- Regulation
- 868.5905
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Mexico | 2 |
| China | 1 |
Makers of Conserver, Oxygen
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 |
|---|---|---|---|---|---|---|---|---|
| Inovo Inc. | Lehigh Acres, FL, United States | Manufacturer, Specification developer | 6 | December 8, 2011 | 0 | 1 | 0 | api.fda.gov |
| Responsive Respiratory Inc. | Saint Louis, MO, United States | Complaint file establishment, Remanufacturer, Repackager or relabeler, Specification developer | 3 | July 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Specification developer | 1 | February 16, 1996 | 0 | 0 | 0 | api.fda.gov |
| Caire Inc. | Ball Ground, GA, United States | Manufacturer | 1 | December 2, 1987 | 0 | 0 | 0 | api.fda.gov |
| Caire Inc. | Ball Ground, GA, United States | Specification developer | 1 | December 2, 1987 | 0 | 0 | 0 | api.fda.gov |
| Dynasthetics | Salt Lake City, UT, United States | Manufacturer | 1 | December 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Incoba LLC Dba Dynaris | Chesterfield, MO, United States | Manufacturer | 1 | November 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Precision Medical, Inc. | Northampton, PA, United States | Manufacturer | 1 | August 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 1 | May 2, 2003 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | March 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Contract manufacturer, Manufacturer | 1 | March 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | May 2, 2003 | 0 | 0 | 0 | api.fda.gov |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 24, 2025. 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.