Renal Systems, Inc.
Mchenry, IL, US
Renal Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Renal Systems, Inc. between 1977 and 1998. The busiest year on record is 1984, with 7. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 1 |
| 1980 | 5 |
| 1981 | 5 |
| 1982 | 4 |
| 1983 | 4 |
| 1984 | 7 |
| 1985 | 4 |
| 1987 | 1 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) | MSF | Substantially Equivalent | |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | FKQ | Substantially Equivalent | |
| K854011 | RENALFO HEMOFILTER CAVHD | KDI | Substantially Equivalent | |
| K844790 | RENAFLO HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | FKX | Substantially Equivalent | |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | FKQ | Substantially Equivalent | |
| K842258 | RENATRON | LIF | Substantially Equivalent | |
| K841543 | CONCENTRATE CONDUCTIVITY METER | FKQ | Substantially Equivalent | |
| K840182 | RENAPAK CONCENTRATE MIXING SYS. | FKQ | Substantially Equivalent | |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | KNZ | Substantially Equivalent | |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | FIQ | Substantially Equivalent | |
| K834596 | BLOOD TUBING | KOC | Substantially Equivalent | |
| K834510 | RENAFLO AVF SET FOR HEMODIALYSIS | KNZ | Substantially Equivalent | |
| K833622 | RENALLOY HEMASITE VASCULAR ACCESS SHUNT | FIQ | Substantially Equivalent | |
| K833181 | HPR HOME PATIENT RENATRON | LIF | Substantially Equivalent | |
| K830575 | RENALIN (TENTATIVE | LIF | Substantially Equivalent | |
| K830574 | RENATRON DIALYZER REPROCESSING SYS | LIF | Substantially Equivalent | |
| K823546 | RENAFLO II | KOC | Substantially Equivalent | |
| K822880 | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS | FIQ | Substantially Equivalent | |
| K821001 | MCPARLAND SCALP VEIN CATHETER | LFJ | Substantially Equivalent | |
| K820221 | HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE | LIF | Substantially Equivalent | |
| K813237 | HEMASITE VASCULAR ACCESS SHUNT HM-1000 | FIQ | Substantially Equivalent | |
| K812890 | HEMASITE GRAFTLESS VASCULAR ACESS | FIQ | Substantially Equivalent | |
| K812230 | MODEL RS 8300 | LIF | Substantially Equivalent | |
| K811977 | HEMASITE ACCESS MONITOR (TENT.) #RS-8200 | KOC | Substantially Equivalent | |
| K811384 | HEMASITE VASCULAR ACCESS SHUNT | FIQ | Substantially Equivalent | |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | FKR | Substantially Equivalent | |
| K801827 | RENAFLO HOLLOW FIBER DIALYZER #100.1 | FJI | Substantially Equivalent | |
| K801826 | RENAFLO HOLLOW FIBER DIALYZERS #MP 140 | FJI | Substantially Equivalent | |
| K801825 | RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. | FJI | Substantially Equivalent | |
| K792213 | RENAL SYSTEMS HEMODIALYSIS CONCENTRATE | KPO | Substantially Equivalent | |
| K781967 | HEMODIALYSIS CONCENTRATE, SODIU | KPO | Substantially Equivalent | |
| K771705 | RS-7800 MINIPUMP | FIR | Substantially Equivalent | |
| K770524 | TRANSDUCER PROTECTOR, RT-901, RT-902 | KOC | Substantially Equivalent | |
| K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE | FLB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNZAccessories, A-V Shunt
- KOCAccessories, Blood Circuit, Hemodialysis
- FIQCannula, A-V Shunt
- LFJCatheter, Subclavian
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- LIFDialyzer Reprocessing System
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- MSFHemodialyzer, Re-Use, High Flux
- FLBMeter, Conductivity, Induction, Remote Type
- FIRPump, Blood, Extra-Luminal
- FKRSubsystem, Proportioning
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FKXSystem, Peritoneal, Automatic Delivery
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain