Data / Medical devices / Device, Blood Mixing And Blood Weighing
Device, Blood Mixing And Blood Weighing (KSQ): 17 FDA-registered makers in 6 countries
17 establishments in 6 countries are registered with the FDA to make Device, Blood Mixing And Blood Weighing (product code KSQ, Class 1, 21 CFR 864.9195). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on August 17, 1984, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSQ
- Device class
- 1
- Regulation
- 864.9195
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| India | 4 |
| China | 3 |
| Germany | 2 |
| South Korea | 1 |
| Poland | 1 |
Makers of Device, Blood Mixing And Blood Weighing
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 |
|---|---|---|---|---|---|---|---|---|
| Applied Science, Inc. | Grass Valley, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boekel Scientific | Feasterville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centron Corporation | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Hemocare GMBH | Friedberg Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesisbps LLC | Mahwah, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HELMER Inc. | Noblesville, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moeller Medical GMBH | FULDA Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remi Elektrotechnik Ltd. | Dist. Palghar Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 17, 1984. 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.