Fresenius Medical Care North America: FDA filings under this applicant name

FDA lists 43 510(k) clearances under 2 spellings of the applicant name “Fresenius Medical Care North America” (first 1998, latest 2025), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 88 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Fresenius Medical Care North America took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.

Top product codes

Plus 4 more product codes.

Review panels

• Gastroenterology and Urology (42)
• General Hospital (1)

Most recent Fresenius Medical Care North America 510(k) clearances

33 earlier clearances. See the full list in Caduvo.

Recalls

12 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2010-05-14.

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.

Device clinical trials

An industry sponsor named Fresenius Medical Care North America is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT04511338: Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ (Completed, started 2020-11-02)
• NCT04573595: Fresenius Noninvasive Blood Pressure Validation (Completed, started 2020-09-17)
• NCT03536663: Clinical Study to Assess the Performance of the Dialyzer With Endexo™ (Completed, started 2018-08-29)
• NCT02334267: Acid-Base Composition With Use of hemoDialysates (Completed, started 2014-11)

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Fresenius Medical Care North America (42)
• Fresenius Medical Care-North America (1)

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 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 North America?

FDA lists 43 510(k) clearances under 2 spellings of the applicant name “Fresenius Medical Care North America” (first 1998, latest 2025), across 14 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 North America?

The median time from FDA receipt to decision across 510(k)s cleared under the name Fresenius Medical Care North America is 88 days.

Which FDA product codes appear under Fresenius Medical Care North America?

The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 17); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 4); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 3).

Next steps

• See all 43 Fresenius Medical Care North America clearances with predicates and recalls
• Run predicate analysis for product code KDI, Fresenius Medical Care North America'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.

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