Renal Solutions, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Renal Solutions, Inc.” (first 2003, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 88 |
| 2013 | 1 | 64 |
| 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 |
|---|---|---|---|
| FKT | System, Dialysate Delivery, Sorbent Regenerated | 6 | 6 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 3 | 3 |
Review panels
Most recent Renal Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | FKT | 2013-02-15 | 64 |
| K121497 | VENOFER PUMP | KDI | 2012-08-17 | 88 |
| K103564 | VENOFER PUMP | KDI | 2011-02-10 | 66 |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | FKT | 2010-08-13 | 289 |
| K093964 | VENOFER PUMP | KDI | 2010-07-09 | 197 |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | FKT | 2007-05-25 | 70 |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | FKT | 2006-05-24 | 99 |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | FKT | 2005-06-03 | 158 |
| K031099 | SORB+HISORB+CARTRIDGE | FKT | 2003-09-17 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Renal Solutions, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Renal Systems, Inc. (35 510(k)s)
- Renal Devices, Inc. (4 510(k)s)
- Renal Care Corp. (2 510(k)s)
- Renal Care Dialysis Solutions, S.A. DE C.V. (1 510(k)s)
- Renal Dynamics, Inc. (1 510(k)s)
- Renal Hygienics (1 510(k)s)
- Renal Scientific Service, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Renal Solutions, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Renal Solutions, Inc.” (first 2003, latest 2013), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Renal Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Renal Solutions, Inc. is 99 days.
Which FDA product codes appear under Renal Solutions, Inc.?
The most frequent FDA product codes under this applicant name are FKT (System, Dialysate Delivery, Sorbent Regenerated, 6); KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 3).
Next steps
- See all 9 Renal Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FKT, Renal Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.