Fresenius USA, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Fresenius USA, Inc.” (first 1984, latest 1999), across 21 product codes in 4 review panels. Median 510(k) review time under this name: 152 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Fresenius Medical Care, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 6 | 6 |
| FKP | System, Dialysate Delivery, Single Patient | 4 | 4 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 4 | 4 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 3 | 3 |
| CEM | Electrode, Ion Specific, Potassium | 2 | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Plus 11 more product codes.
Review panels
- Gastroenterology and Urology (27)
- Clinical Chemistry (4)
- Cardiovascular (3)
- Dental (2)
Most recent Fresenius USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS | KDI | 1999-08-04 | 28 |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | MSE | 1998-09-15 | 567 |
| K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS | KDI | 1998-05-14 | 157 |
| K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 | CAC | 1997-11-03 | 56 |
| K961465 | 2008H ON LINE CLEARANCE MONITOR | KDI | 1997-07-03 | 442 |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | LKN | 1996-07-31 | 90 |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | KPF | 1996-07-31 | 226 |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | MQS | 1996-07-03 | 831 |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | FKP | 1996-06-13 | 198 |
| K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER | FIP | 1995-11-29 | 428 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fresenius USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fresenius Medical Care Renal Therapies Group, LLC (52 510(k)s)
- Fresenius Medical Care North America (43 510(k)s)
- Fresenius Kabi AG (12 510(k)s)
- Fresenius Medical Care (7 510(k)s)
- Fresenius Medical Care North America, Design Cente (5 510(k)s)
- Fresenius Hemotechnology, Inc. (3 510(k)s)
- Fresenius Pharma (3 510(k)s)
- Fresenius AG (2 510(k)s)
- Fresenius/Delmed, Inc. (2 510(k)s)
- Fresenius Kabi (2 510(k)s)
- Fresenius Kabi USA,Llc (2 510(k)s)
- Fresenius Medical Care South Asia Pacific Pty , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fresenius USA, Inc.?
FDA lists 38 510(k) clearances under the applicant name “Fresenius USA, Inc.” (first 1984, latest 1999), across 21 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fresenius USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fresenius USA, Inc. is 152 days.
Which FDA product codes appear under Fresenius USA, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 6); FKP (System, Dialysate Delivery, Single Patient, 4); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 4).
Next steps
- See all 38 Fresenius USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Fresenius USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.