Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renal Solutions, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
289 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2013-02-15 | 64 | 0 |
| K121497 | VENOFER PUMP | Renal Solutions, Inc. | 2012-08-17 | 88 | 1 |
| K103564 | VENOFER PUMP | Renal Solutions, Inc. | 2011-02-10 | 66 | 0 |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2010-08-13 | 289 | 0 |
| K093964 | VENOFER PUMP | Renal Solutions, Inc. | 2010-07-09 | 197 | 0 |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | Renal Solutions, Inc. | 2007-05-25 | 70 | 0 |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | Renal Solutions, Inc. | 2006-05-24 | 99 | 0 |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Renal Solutions, Inc. | 2005-06-03 | 158 | 0 |
| K031099 | SORB+HISORB+CARTRIDGE | Renal Solutions, Inc. | 2003-09-17 | 163 | 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