Fresenius Medical Care North America, Design Cente: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Fresenius Medical Care North America, Design Cente” (first 2010, latest 2013), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 186 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 | 2 | 51 |
| 2013 | 2 | 269 |
| 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 | 2 | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| ONW | Hemodialysis System For Home Use | 1 | 1 |
Review panels
Most recent Fresenius Medical Care North America, Design Cente 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123630 | FRESENIUS LIBERTY CYCLER | FKX | 2013-09-09 | 290 |
| K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) | ONW | 2013-01-17 | 248 |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | FJK | 2012-06-15 | 88 |
| K120505 | FRESENIUS 2008T HEMODIALYSIS MACHINE | KDI | 2012-03-06 | 14 |
| K101715 | FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 | KDI | 2010-12-21 | 186 |
Recalls
openFDA lists no recalls under a recalling firm named Fresenius Medical Care North America, Design Cente.
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 (42 510(k)s)
- Fresenius USA, Inc. (38 510(k)s)
- Fresenius Kabi AG (12 510(k)s)
- Fresenius Medical Care (7 510(k)s)
- Fresenius Hemotechnology, Inc. (3 510(k)s)
- Fresenius Pharma (3 510(k)s)
- Fresenius AG (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)
- Fresenius Kabi Deutschland GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fresenius Medical Care North America, Design Cente?
FDA lists 5 510(k) clearances under the applicant name “Fresenius Medical Care North America, Design Cente” (first 2010, latest 2013), across 4 product codes in 1 review panel. 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 North America, Design Cente?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fresenius Medical Care North America, Design Cente is 186 days.
Which FDA product codes appear under Fresenius Medical Care North America, Design Cente?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 2); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 1); FKX (System, Peritoneal, Automatic Delivery, 1).
Next steps
- See all 5 Fresenius Medical Care North America, Design Cente clearances with predicates and recalls
- Run predicate analysis for product code KDI, Fresenius Medical Care North America, Design Cente'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.