Data / Medical devices / Dialyzer Reprocessing System
Dialyzer Reprocessing System (LIF): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Dialyzer Reprocessing System (product code LIF, Class 2, 21 CFR 876.5820). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 57 510(k) clearances under this code, the latest on November 3, 2010, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- LIF
- Device class
- 2
- Regulation
- 876.5820
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Dialyzer Reprocessing System
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 |
|---|---|---|---|---|---|---|---|---|
| Evoqua Water Technologies LLC | Minneapolis, MN, United States | Manufacturer | 2 | November 27, 1990 | 0 | 0 | 0 | api.fda.gov |
| Reprocessing Products Corporation (RPC) | Tucson, AZ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | February 10, 1999 | 0 | 0 | 0 | api.fda.gov |
| Serim Research Corp. | Elkhart, IN, United States | Manufacturer | 2 | April 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| Molded Products Inc. | Harlan, IA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | February 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| Novaflux, Inc. | Princeton, NJ, United States | Manufacturer | 1 | November 3, 2010 | 0 | 0 | 0 | api.fda.gov |
| IBT Scientific | Creedmoor, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2010. 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.