Renal Systems, Inc.: FDA clearances and approvals
Renal Systems, Inc. has 35 FDA 510(k) clearances (first 1977, latest 1998), across 14 product codes in 1 review panel. Median 510(k) review time: 36 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FIQ | Cannula, A-V Shunt | 6 | 6 |
| LIF | Dialyzer Reprocessing System | 6 | 6 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 4 | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 3 | 3 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | 2 |
| KNZ | Accessories, A-V Shunt | 2 | 2 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 2 | 2 |
| FIR | Pump, Blood, Extra-Luminal | 1 | 1 |
| FKR | Subsystem, Proportioning | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Renal Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) | MSF | 1998-01-05 | 319 |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | FKQ | 1987-06-09 | 399 |
| K854011 | RENALFO HEMOFILTER CAVHD | KDI | 1985-11-05 | 36 |
| K844790 | RENAFLO HEMOCONCENTRATOR | KDI | 1985-05-23 | 164 |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | FKX | 1985-01-07 | 76 |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | FKQ | 1985-01-07 | 88 |
| K842258 | RENATRON | LIF | 1984-07-06 | 29 |
| K841543 | CONCENTRATE CONDUCTIVITY METER | FKQ | 1984-05-22 | 36 |
| K840182 | RENAPAK CONCENTRATE MIXING SYS. | FKQ | 1984-05-02 | 106 |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | KNZ | 1984-02-21 | 20 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Renal Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Renal Systems, Inc. have?
Renal Systems, Inc. has 35 FDA 510(k) clearances (first 1977, latest 1998), across 14 product codes in 1 review panel.
How long does FDA take to clear Renal Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Renal Systems, Inc.'s cleared 510(k)s is 36 days.
What devices does Renal Systems, Inc. make?
Its most frequent FDA product codes are FIQ (Cannula, A-V Shunt, 6); LIF (Dialyzer Reprocessing System, 6); FKQ (System, Dialysate Delivery, Central Multiple Patient, 4).
Has Renal Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Renal Systems, Inc. Related entities may recall under other names.
Next steps
- See all 35 Renal Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIQ, Renal Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.