Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of STERISLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Renal Systems, Inc. with 35 510(k) clearances. The most recent is a 510(k) clearance dated Jan 5, 1998: PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S).
| Jan 5, 1998 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)K970648 · MSF | 510(k) clearances |
| Jun 9, 1987 | ACTRIL FOR KIDNEY MACHINE DISINFECTANTK861730 · FKQ | 510(k) clearances |
| Nov 5, 1985 | RENALFO HEMOFILTER CAVHDK854011 · KDI | 510(k) clearances |
| May 23, 1985 | RENAFLO HEMOCONCENTRATORK844790 · KDI | 510(k) clearances |
| Jan 7, 1985 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK843963 · FKQ | 510(k) clearances |
| Jan 7, 1985 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEMK844108 · FKX | 510(k) clearances |
| Jul 6, 1984 | RENATRONK842258 · LIF | 510(k) clearances |
| May 22, 1984 | CONCENTRATE CONDUCTIVITY METERK841543 · FKQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
