FDA applicant

Fresenius Medical Care, North America - Renal Ther

Waltham, MA1 decision2014–20140 recalls

FDA records 1 decision for Fresenius Medical Care, North America - Renal Ther (Waltham, MA) in 2014: 1 510(k) clearance. All are in product code KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Fresenius Medical Care, North America - Renal Ther’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Fresenius Medical Care, North America - Renal Ther by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Fresenius”

FDA records each applicant name separately; these may or may not be the same firm.

Fresenius Medical Care Renal Therapies Group, LLC 53 Fresenius Medical Care North America 43 Fresenius USA, Inc. 38 Fresenius Kabi AG 14 Fresenius Medical Care 7 Fresenius Medical Care North America, Design Cente 5 Fresenius Hemotechnology, Inc. 3 Fresenius Pharma 3 Fresenius AG 2 Fresenius Medical Care South Asia Pacific Pty, Ltd. 2 Fresenius Kabi USA,Llc 2 Fresenius/Delmed, Inc. 2

Fresenius Medical Care, North America - Renal Ther

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Fresenius”