510(k) Report

FDA applicant

B.Braun Melsungen AG

Melsungen, DE5 decisions2011–20171 recall

FDA records 5 decisions for B.Braun Melsungen AG (Melsungen, DE) from 2011 to 2017: 5 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 6 predicates, 1 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, general hospital panel, where it files most

How often FDA has decided B.Braun Melsungen AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 22013: 12016: 12017: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2011high 1 (2025) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — B.Braun Melsungen AG by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • DRSTransducer, Blood-Pressure, Extravascular1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) /…B.Braun Melsungen AG · 20113cite it
  • K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 20171cites it
  • K152050PencylcapB.Braun Melsungen AG · 20161cites it

What has FDA decided for it lately?

  • K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
  • K152050PencylcapB.Braun Melsungen AG · 2016
  • K131040Extavipro Sterican 30GB.Braun Melsungen AG · 2013
  • K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) /…B.Braun Melsungen AG · 20111 recall
  • K102033Combitrans Monitoring Sets and AccessoriesB.Braun Melsungen AG · 2011

All 5 as B.Braun Melsungen AG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K182870Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV…Feb 17, 2025Class II