Fresenius Medical Care Renal Therapies Group, LLC: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Fresenius Medical Care Renal Therapies Group, LLC” (first 2013, latest 2026), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 148 days. Since 2017 the median was 163 days, against 198 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 107 |
| 2014 | 2 | 90 |
| 2015 | 1 | 266 |
| 2016 | 2 | 88 |
| 2017 | 3 | 141 |
| 2018 | 6 | 111 |
| 2019 | 2 | 155 |
| 2020 | 7 | 268 |
| 2021 | 0 | — |
| 2022 | 5 | 247 |
| 2023 | 4 | 326 |
| 2024 | 4 | 178 |
| 2025 | 11 | 116 |
| 2026 | 4 | 152 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fresenius Medical Care Renal Therapies Group, LLC took a median 163 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 19 | 19 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 10 | 10 |
| FKX | System, Peritoneal, Automatic Delivery | 6 | 6 |
| FIP | Subsystem, Water Purification | 4 | 4 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 4 | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 | 4 |
| QJZ | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | 2 | 2 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
Review panels
Most recent Fresenius Medical Care Renal Therapies Group, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500 | KDI | 2026-07-24 | 99 |
| K252377 | NxStage System One with NxView | KDI | 2026-05-15 | 289 |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | KDI | 2026-02-10 | 189 |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | 2026-01-29 | 114 |
| K253518 | FX CorAL 40; FX CorAL 50 | KDI | 2025-12-18 | 36 |
| K250634 | BCM2-Body Composition Monitor | DSB | 2025-11-24 | 266 |
| K250471 | AquaC UNO H | FIP | 2025-11-14 | 269 |
| K251851 | DIASAFEplusUS (F00013010) | FIP | 2025-10-09 | 115 |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | KPO | 2025-09-09 | 60 |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | KDI | 2025-06-13 | 246 |
42 earlier clearances. See the full list in Caduvo.
Recalls
34 product recalls in 21 recall events; 9 initiated in the last five years. Most recent: 2026-08-10.
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 North America (43 510(k)s)
- Fresenius USA, Inc. (38 510(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 Medical Care Renal Therapies Group, LLC?
FDA lists 52 510(k) clearances under the applicant name “Fresenius Medical Care Renal Therapies Group, LLC” (first 2013, latest 2026), across 10 product codes in 2 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 Medical Care Renal Therapies Group, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fresenius Medical Care Renal Therapies Group, LLC is 148 days. Since 2017: 163 days, versus 198 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fresenius Medical Care Renal Therapies Group, LLC?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 19); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 10); FKX (System, Peritoneal, Automatic Delivery, 6).
Next steps
- See all 52 Fresenius Medical Care Renal Therapies Group, LLC clearances with predicates and recalls
- Run predicate analysis for product code KDI, Fresenius Medical Care Renal Therapies Group, LLC'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.