510(k) Report

FDA applicant

Fresensius Medical Care North America

Waltham, MA1 decision2013–20131 recall

FDA records 1 decision for Fresensius Medical Care North America (Waltham, MA) in 2013: 1 510(k) clearance. All are in product code KDJ (Set, Administration, For Peritoneal Dialysis…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Fresensius Medical Care North America’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2013high 1 (2021) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Fresensius Medical Care North America by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fresensius Medical Care North America’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KDJSet, Administration, For Peritoneal Dialysis, Disposable1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K124024Apd Luer-Lock AdapterFresensius Medical Care North America · 20131 recall

The one decision as Fresensius Medical Care North America →

What has been recalled?

1 recall linked to its devices; the latest:

  • K124024The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a…Apr 28, 2021Class II