Renal Solutions, Inc.
Apollo, PA, US
Renal Solutions, Inc. appears in FDA device records in Apollo, PA. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Renal Solutions, Inc. between 2003 and 2013. The busiest year on record is 2010, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | FKT | Substantially Equivalent | |
| K121497 | VENOFER PUMP | KDI | Substantially Equivalent | |
| K103564 | VENOFER PUMP | KDI | Substantially Equivalent | |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | FKT | Substantially Equivalent | |
| K093964 | VENOFER PUMP | KDI | Substantially Equivalent | |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | FKT | Substantially Equivalent | |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | FKT | Substantially Equivalent | |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | FKT | Substantially Equivalent | |
| K031099 | SORB+HISORB+CARTRIDGE | FKT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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