510(k) Report

FDA applicant

B. Braun Instruments

Mchenry, IL13 decisions1976–19768 recalls

FDA records 13 decisions for B. Braun Instruments (Mchenry, IL) in 1976: 13 510(k) clearances. Most are in product codes JCY (Catheter, Infusion) and KGZ (Accessories, Catheter). 8 recalls are 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for B. Braun Instruments since 2007.

Recalls per year

3in 2025

2009: 12014: 12016: 12022: 12025: 3
2007high 3 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JCYCatheter, Infusion4decisions
  • KGZAccessories, Catheter3decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions
  • FMFSyringe, Piston1decision
  • FGYCannula, Injection1decision
  • GCDConnector, Catheter1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K760385Extension SetsB. Braun Instruments · 19761cites it
  • K760392SyringesB. Braun Instruments · 19761cites it

What has FDA decided for it lately?

  • K760385Extension SetsB. Braun Instruments · 1976
  • K760390Catheter, Vein (Braunula T)B. Braun Instruments · 1976
  • K760388Catheter, Vein (Venofix)B. Braun Instruments · 19761 recall
  • K760383StopcocksB. Braun Instruments · 19766 recalls
  • K760380Intravenous Transfer Set (Intrafix)B. Braun Instruments · 1976
  • K760392SyringesB. Braun Instruments · 19761 recall
  • K760389Cannula, IVB. Braun Instruments · 1976
  • K760382ConnectorsB. Braun Instruments · 1976

All 13 as B. Braun Instruments →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K760383IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K760383IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K760383IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K760392Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152May 25, 2022Class II
  • K760388WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through…Apr 26, 2016Class II
  • K060231SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device…Jan 8, 2014Class II