Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fresenius Medical Care · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
252 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024-02-02 | 248 | 1 |
| K141997 | CRIT-LINE IV SYSTEM | Fresenius Medical Care | 2015-04-01 | 252 | 0 |
| K111639 | FRESENIUS 2008T HEMODIALYSIS MACHINE | Fresenius Medical Care | 2011-10-21 | 130 | 1 |
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERI | Fresenius Medical Care | 2003-05-20 | 90 | 11 |
| K023162 | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS | Fresenius Medical Care | 2003-03-20 | 178 | 0 |
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDA | Fresenius Medical Care | 2002-10-30 | 90 | 3 |
| K994267 | FRESENIUS 2008K | Fresenius Medical Care | 2000-03-16 | 90 | 5 |
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