Data / Medical devices / Meter, Airway Pressure (Inspiratory Force)
Meter, Airway Pressure (Inspiratory Force) (BXR): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Meter, Airway Pressure (Inspiratory Force) (product code BXR, Class 2, 21 CFR 868.1780). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on September 11, 2008, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BXR
- Device class
- 2
- Regulation
- 868.1780
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Malaysia | 1 |
Makers of Meter, Airway Pressure (Inspiratory Force)
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 |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | March 9, 1988 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer, Specification developer | 1 | September 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 1 | February 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 2008. 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.