Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fresenius USA, Inc. · Predicate Candidate Screening
38 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
754 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & | Fresenius USA, Inc. | 1999-08-04 | 28 | 0 |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | Fresenius USA, Inc. | 1998-09-15 | 567 | 0 |
| K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F40 | Fresenius USA, Inc. | 1998-05-14 | 157 | 0 |
| K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT | Fresenius USA, Inc. | 1997-11-03 | 56 | 0 |
| K961465 | 2008H ON LINE CLEARANCE MONITOR | Fresenius USA, Inc. | 1997-07-03 | 442 | 0 |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PR | Fresenius USA, Inc. | 1996-07-31 | 226 | 0 |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE | Fresenius USA, Inc. | 1996-07-31 | 90 | 1 |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | Fresenius USA, Inc. | 1996-07-03 | 831 | 0 |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-06-13 | 198 | 0 |
| K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | Fresenius USA, Inc. | 1995-11-29 | 1049 | 0 |
| K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER | Fresenius USA, Inc. | 1995-11-29 | 428 | 0 |
| K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE | Fresenius USA, Inc. | 1994-10-17 | 896 | 0 |
| K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS | Fresenius USA, Inc. | 1994-08-23 | 634 | 0 |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | Fresenius USA, Inc. | 1994-04-20 | 754 | 3 |
| K922005 | GRANULYTE DIALYSATE CONCENTRATE | Fresenius USA, Inc. | 1994-03-30 | 700 | 0 |
| K921134 | FRESENIUS POLYSULFONE DIALYZERS | Fresenius USA, Inc. | 1993-12-02 | 632 | 0 |
| K915634 | FRESENIUS PD+ EXCHANGE DEVICE | Fresenius USA, Inc. | 1993-07-01 | 562 | 0 |
| K921052 | FRESENIUS VARIABLE FILL MONITOR | Fresenius USA, Inc. | 1993-02-25 | 357 | 0 |
| K912208 | FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE | Fresenius USA, Inc. | 1991-07-24 | 65 | 0 |
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING | Fresenius USA, Inc. | 1991-07-17 | 105 | 1 |
| K904806 | CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR | Fresenius USA, Inc. | 1991-01-11 | 79 | 0 |
| K895435 | FRESENIUS AS 104 CELL SEPARATOR | Fresenius USA, Inc. | 1990-11-02 | 421 | 0 |
| K902394 | RESUBMITTED MULTIORGAN PERFUSION CANNULA | Fresenius USA, Inc. | 1990-09-27 | 120 | 0 |
| K901042 | IONOMETER EF-HK AND ACCESSORIES | Fresenius USA, Inc. | 1990-07-31 | 147 | 0 |
| K901040 | IONOMETER EH-F AND ACCESSORIES | Fresenius USA, Inc. | 1990-07-19 | 135 | 0 |
| K901039 | IONOMETER EH | Fresenius USA, Inc. | 1990-06-28 | 114 | 0 |
| K901041 | IONOMETER EH-HK AND ACCESSORIES | Fresenius USA, Inc. | 1990-06-18 | 104 | 0 |
| K895366 | ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE | Fresenius USA, Inc. | 1990-05-02 | 247 | 0 |
| K896111 | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB | Fresenius USA, Inc. | 1989-12-27 | 65 | 0 |
| K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 | 108 | 0 |
| K890824 | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 | 83 | 0 |
| K892262 | FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M | Fresenius USA, Inc. | 1989-04-25 | 20 | 0 |
| K884609 | EURO-COLLINS SOLUTION SETS | Fresenius USA, Inc. | 1989-01-26 | 80 | 0 |
| K883195 | FRESENIUS F8 DIALYZER | Fresenius USA, Inc. | 1988-09-13 | 47 | 0 |
| K881155 | MODEL BPS08 BLOOD PRESSURE MODULE | Fresenius USA, Inc. | 1988-07-28 | 132 | 0 |
| K874106 | GLANDOSANE (SALIVART) SYNTHETIC SALIVA | Fresenius USA, Inc. | 1988-04-15 | 189 | 0 |
| K841104 | ENTERNAL FEEDING PUMP BATTERY OPER. | Fresenius USA, Inc. | 1985-04-30 | 412 | 0 |
| K841718 | FREKATHETER VENOUS CATHETERISATION SYS | Fresenius USA, Inc. | 1984-04-25 | 0 | 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