Data / Medical devices / Calibrator, Pressure, Gas
Calibrator, Pressure, Gas (BXX): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Calibrator, Pressure, Gas (product code BXX, Class 1, 21 CFR 868.2620). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on September 14, 1992, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BXX
- Device class
- 1
- Regulation
- 868.2620
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Calibrator, Pressure, Gas
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 |
|---|---|---|---|---|---|---|---|---|
| Escalon Medical Corp | New Berlin, WI, United States | Manufacturer | 1 | September 14, 1992 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 1992. 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.