510(k) Report

FDA applicant

B. Braun Medizintechnologie GmbH

Melsungen, DE3 decisions2006–20081 recall

FDA records 3 decisions for B. Braun Medizintechnologie GmbH (Melsungen, DE) from 2006 to 2008: 3 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FKQ (System, Dialysate Delivery, Central Multiple…). Its devices cite 4 predicates, 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 B. Braun Medizintechnologie GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — B. Braun Medizintechnologie GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like B. Braun Medizintechnologie GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision
  • FKQSystem, Dialysate Delivery, Central Multiple Patient1decision
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071518Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) HemodialyzersB. Braun Medizintechnologie GmbH · 20073cite it
  • K072760Solcart BB. Braun Medizintechnologie GmbH · 20082cite it

What has FDA decided for it lately?

  • K072760Solcart BB. Braun Medizintechnologie GmbH · 2008
  • K071518Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) HemodialyzersB. Braun Medizintechnologie GmbH · 2007
  • K052764Diacap Ultra Dialysis Fluid FilterB. Braun Medizintechnologie GmbH · 20061 recall

All 3 as B. Braun Medizintechnologie GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052764Diacap (R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter…Mar 1, 2013Class II