Data / Medical devices / Data Acquisition Software
Data Acquisition Software (PQQ): 8 FDA-registered makers in 7 countries
8 establishments in 7 countries are registered with the FDA to make Data Acquisition Software (product code PQQ, Class 2, 21 CFR 862.2570). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PQQ
- Device class
- 2
- Regulation
- 862.2570
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| South Korea | 2 |
| United Kingdom | 1 |
| United States | 1 |
| China | 1 |
| Germany | 1 |
| Switzerland | 1 |
| Taiwan | 1 |
Makers of Data Acquisition Software
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 |
|---|---|---|---|---|---|---|---|---|
| Biomedical Data Solutions Limited | BURTON ON TRENT Staffordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Data Innovations, LLC | Colchester, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Human Metabolomics Institute, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hurotics Inc. | Dongjak District Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M20 Co.,ltd. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeoPredics AG | Regensburg Bavaria, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yankang Medical Instrument Co., Ltd. | Taipei, Taiwan | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.