Data / Medical devices / Calculator, Predicted Values, Pulmonary Function
Calculator, Predicted Values, Pulmonary Function (BTY): 13 FDA-registered makers in 7 countries
13 establishments in 7 countries are registered with the FDA to make Calculator, Predicted Values, Pulmonary Function (product code BTY, Class 2, 21 CFR 868.1890). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 64 510(k) clearances under this code, the latest on August 20, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BTY
- Device class
- 2
- Regulation
- 868.1890
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| Switzerland | 3 |
| United States | 3 |
| Italy | 1 |
| China | 1 |
| Ireland | 1 |
| Mexico | 1 |
Makers of Calculator, Predicted Values, Pulmonary Function
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 |
|---|---|---|---|---|---|---|---|---|
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 9 | November 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| eResearchTechnology GmbH | Estenfeld Bavaria, Germany | Complaint file establishment, Manufacturer | 8 | May 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cosmed S.R.L. | Albano Laziale, Roma, Italy | Exporter to the US, Manufacturer | 3 | February 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| NDD Medizintechnik AG | Zurich, Switzerland | Complaint file establishment, Specification developer | 3 | February 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medical Graphics Corp. | Saint Paul, MN, United States | Manufacturer | 2 | October 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shape Medical Systems, Inc | Saint Paul, MN, United States | Manufacturer | 2 | January 21, 2016 | 0 | 2 | 0 | api.fda.gov |
| Cortex Biophysik GMBH | LEIPZIG Saxony, Germany | Manufacturer | 1 | December 14, 2000 | 0 | 0 | 0 | api.fda.gov |
| Elfo AG | Sachseln Obwalden, Switzerland | Manufacturer | 1 | February 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Homesun Medical Technology Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 1 | February 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Vitalograph Ireland Ltd. | Co Clare, Ireland | Manufacturer | 1 | July 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TreyMed, Inc. | Sussex, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zollner Electronics GMBH | Hombrechtikon Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 20, 2026. 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.