Data / Medical devices / System, Processing For Frozen Blood
System, Processing For Frozen Blood (KSW): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make System, Processing For Frozen Blood (product code KSW, Class 2, 21 CFR 864.9145). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 23, 1976, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSW
- Device class
- 2
- Regulation
- 864.9145
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Malta | 1 |
| Mexico | 1 |
| Malaysia | 1 |
Makers of System, Processing For Frozen Blood
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 |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Cleveland, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Marion, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Limited | Marsa, Malta | Specification developer | 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 | |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Mexico Manufacturing S. de R.L. de C.V. | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina-SCI Systems (Malaysia) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo BCT, Inc.. | Lakewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 23, 1976. 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.