Renal Solutions, Inc. FDA Record
Renal Solutions, Inc. has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Renal Solutions, Inc." is on file.
- Latest 510(k)
- Feb 15, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Feb 15, 2013 |
| K121497 | VENOFER PUMP | Aug 17, 2012 |
| K103564 | VENOFER PUMP | Feb 10, 2011 |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Aug 13, 2010 |
| K093964 | VENOFER PUMP | Jul 9, 2010 |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | May 25, 2007 |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | May 24, 2006 |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Jun 3, 2005 |
| K031099 | SORB+HISORB+CARTRIDGE | Sep 17, 2003 |
Renal Solutions, Inc. and the FDA: common questions
Has Renal Solutions, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Renal Solutions, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Renal Solutions, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Renal Solutions, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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