Data / Medical devices / Accessories, Blood Circuit, Hemodialysis
Accessories, Blood Circuit, Hemodialysis (KOC): 21 FDA-registered makers in 7 countries
21 establishments in 7 countries are registered with the FDA to make Accessories, Blood Circuit, Hemodialysis (product code KOC, Class 2, 21 CFR 876.5820). 12 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 182 510(k) clearances under this code, the latest on May 15, 2025, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KOC
- Device class
- 2
- Regulation
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 5 |
| Germany | 3 |
| Vietnam | 1 |
| Tunisia | 1 |
| Canada | 1 |
| Thailand | 1 |
Makers of Accessories, Blood Circuit, Hemodialysis
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 |
|---|---|---|---|---|---|---|---|---|
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 5 | September 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 5 | September 18, 2020 | 0 | 5 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 4 | September 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Innovations For Access, Inc. | Hillsboro, OR, United States | Complaint file establishment, Manufacturer | 2 | March 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| M.E.Nikkiso Vietnam Co., Ltd. | Quang Ngai, Vietnam | Manufacturer | 2 | May 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 2 | July 7, 2008 | 0 | 0 | 0 | api.fda.gov |
| Stihler Electronic GMBH | Leinfelden-Echterdingen Baden-Wurttemberg, Germany | Manufacturer | 2 | December 19, 2008 | 0 | 1 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 1 | March 7, 1977 | 0 | 0 | 0 | api.fda.gov |
| Bieffe Medital Manufacturing Oued Ellil Tunisia | Oued Ellil Manouba, Tunisia | Manufacturer | 1 | January 5, 1983 | 0 | 0 | 0 | api.fda.gov |
| Erika of Texas | Pharr, TX, United States | Manufacturer | 1 | April 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 1 | May 16, 2001 | 0 | 2 | 0 | api.fda.gov |
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Specification developer | 1 | May 27, 1982 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diseno Electronico Mexicano SA De CV | IMURIS Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Deutschland GMBH | ST. WENDEL Saarland, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Deutschland GMBH | SCHWEINFURT Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius USA Manufacturing, Inc. | Oregon, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotronic De Mexico S De RL | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotec, a division of Fresenius Medical Care Canada Inc. | VAUDREUIL-DORION Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nipro (Thailand) Corporation Limited | SENA Phra Nakhon Si Ayutthaya, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 15, 2025. 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.