Fresenius Medical Care: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Fresenius Medical Care” (first 2000, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 130 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 | 1 | 252 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 248 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fresenius Medical Care took a median 248 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 3 | 3 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Review panels
Most recent Fresenius Medical Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231534 | 5008X Hemodialysis System | KDI | 2024-02-02 | 248 |
| K141997 | CRIT-LINE IV SYSTEM | KOC | 2015-04-01 | 252 |
| K111639 | FRESENIUS 2008T HEMODIALYSIS MACHINE | KDI | 2011-10-21 | 130 |
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES | KPO | 2003-05-20 | 90 |
| K023162 | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS | FIE | 2003-03-20 | 178 |
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR | KOC | 2002-10-30 | 90 |
| K994267 | FRESENIUS 2008K | KDI | 2000-03-16 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Fresenius Medical Care.
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 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 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?
FDA lists 7 510(k) clearances under the applicant name “Fresenius Medical Care” (first 2000, latest 2024), 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fresenius Medical Care is 130 days.
Which FDA product codes appear under Fresenius Medical Care?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 3); KOC (Accessories, Blood Circuit, Hemodialysis, 2); FIE (Needle, Fistula, 1).
Next steps
- See all 7 Fresenius Medical Care clearances with predicates and recalls
- Run predicate analysis for product code KDI, Fresenius Medical Care'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.