510(k) Report

FDA applicant

B. Braun Melsugen AG

Melsungen, DE1 decision2020–20208 recalls

FDA records 1 decision for B. Braun Melsugen AG (Melsungen, DE) in 2020: 1 510(k) clearance. All are in product code MRZ (Accessories, Pump, Infusion). Its devices cite 3 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices, 3 Class I.

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 Melsugen AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

5in 2024

2022: 12023: 2, 2 Class I2024: 5, 1 Class I
2020high 5 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — B. Braun Melsugen AG by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRZAccessories, Pump, Infusion1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K191910SpaceStation MRIB. Braun Melsugen AG · 20203 Class I recalls

The one decision as B. Braun Melsugen AG →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K191910Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050UAug 7, 2024Class I
  • K191910Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number…Jun 14, 2024Class II
  • K172831Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System…Jun 14, 2024Class II
  • K172831Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless…Jun 14, 2024Class II
  • K172831Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless…Jun 14, 2024Class II
  • K1425968713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump SystemSep 21, 2023Class I