Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renal Systems, Inc. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
106 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2 | Renal Systems, Inc. | 1998-01-05 | 319 | 0 |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | Renal Systems, Inc. | 1987-06-09 | 399 | 0 |
| K854011 | RENALFO HEMOFILTER CAVHD | Renal Systems, Inc. | 1985-11-05 | 36 | 0 |
| K844790 | RENAFLO HEMOCONCENTRATOR | Renal Systems, Inc. | 1985-05-23 | 164 | 0 |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | Renal Systems, Inc. | 1985-01-07 | 88 | 0 |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | Renal Systems, Inc. | 1985-01-07 | 76 | 0 |
| K842258 | RENATRON | Renal Systems, Inc. | 1984-07-06 | 29 | 0 |
| K841543 | CONCENTRATE CONDUCTIVITY METER | Renal Systems, Inc. | 1984-05-22 | 36 | 0 |
| K840182 | RENAPAK CONCENTRATE MIXING SYS. | Renal Systems, Inc. | 1984-05-02 | 106 | 0 |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | Renal Systems, Inc. | 1984-02-21 | 20 | 0 |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1984-02-21 | 20 | 0 |
| K834596 | BLOOD TUBING | Renal Systems, Inc. | 1984-02-04 | 36 | 0 |
| K834510 | RENAFLO AVF SET FOR HEMODIALYSIS | Renal Systems, Inc. | 1984-02-04 | 45 | 0 |
| K833622 | RENALLOY HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1983-11-29 | 46 | 0 |
| K833181 | HPR HOME PATIENT RENATRON | Renal Systems, Inc. | 1983-10-27 | 38 | 0 |
| K830575 | RENALIN (TENTATIVE | Renal Systems, Inc. | 1983-03-31 | 36 | 0 |
| K830574 | RENATRON DIALYZER REPROCESSING SYS | Renal Systems, Inc. | 1983-03-29 | 34 | 0 |
| K823546 | RENAFLO II | Renal Systems, Inc. | 1982-12-16 | 16 | 0 |
| K822880 | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS | Renal Systems, Inc. | 1982-10-18 | 27 | 0 |
| K821001 | MCPARLAND SCALP VEIN CATHETER | Renal Systems, Inc. | 1982-07-22 | 105 | 0 |
| K820221 | HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE | Renal Systems, Inc. | 1982-03-23 | 55 | 0 |
| K813237 | HEMASITE VASCULAR ACCESS SHUNT HM-1000 | Renal Systems, Inc. | 1981-11-30 | 20 | 0 |
| K812890 | HEMASITE GRAFTLESS VASCULAR ACESS | Renal Systems, Inc. | 1981-11-16 | 32 | 0 |
| K812230 | MODEL RS 8300 | Renal Systems, Inc. | 1981-11-06 | 87 | 0 |
| K811384 | HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1981-07-31 | 73 | 0 |
| K811977 | HEMASITE ACCESS MONITOR (TENT.) #RS-8200 | Renal Systems, Inc. | 1981-07-31 | 18 | 0 |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | Renal Systems, Inc. | 1980-11-12 | 34 | 0 |
| K801825 | RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. | Renal Systems, Inc. | 1980-09-26 | 57 | 0 |
| K801826 | RENAFLO HOLLOW FIBER DIALYZERS #MP 140 | Renal Systems, Inc. | 1980-09-26 | 57 | 0 |
| K801827 | RENAFLO HOLLOW FIBER DIALYZER #100.1 | Renal Systems, Inc. | 1980-09-26 | 57 | 0 |
| K792213 | RENAL SYSTEMS HEMODIALYSIS CONCENTRATE | Renal Systems, Inc. | 1980-01-04 | 63 | 0 |
| K781967 | HEMODIALYSIS CONCENTRATE, SODIU | Renal Systems, Inc. | 1978-12-07 | 13 | 0 |
| K771705 | RS-7800 MINIPUMP | Renal Systems, Inc. | 1977-10-04 | 25 | 0 |
| K770524 | TRANSDUCER PROTECTOR, RT-901, RT-902 | Renal Systems, Inc. | 1977-03-30 | 12 | 0 |
| K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE | Renal Systems, Inc. | 1977-02-18 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda