510(k) Report

FDA applicant

B. Braun Avitum AG

Allentown, PA6 decisions1997–20178 recalls

FDA records 6 decisions for B. Braun Avitum AG (Allentown, PA) from 1997 to 2017: 5 510(k) clearances and 1 original PMA approval. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 5 predicates, 1 of them its own earlier devices. 8 recalls are linked to its devices, 6 Class I.

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

FDA decisions per year

1in 2017

2010: 22011: 12016: 12017: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2022

2016: 6, 6 Class I2022: 2
2007high 6 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like B. Braun Avitum AG’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 System4decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)1decision
  • MMYLipoprotein, Low Density, Removal1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K083460Dialog with Adimea OptionB. Braun Avitum AG · 20102cite it
  • K100334Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811B. Braun Avitum AG · 20101cites it
  • K102194Solcart BB. Braun Avitum AG · 20111cites it

What has FDA decided for it lately?

  • K170574Diacap Pro DialyzerB. Braun Avitum AG · 2017
  • K143482xevonta dialyzerB. Braun Avitum AG · 2016
  • K102194Solcart BB. Braun Avitum AG · 2011
  • K100334Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811B. Braun Avitum AG · 2010
  • K083460Dialog with Adimea OptionB. Braun Avitum AG · 20106 Class I recalls
  • P940016H.E.L.P. SystemB. Braun Avitum AG · 1997

All 6 as B. Braun Avitum AG →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K083460Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity…Jan 28, 2022Class II
  • K083460Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity…Jan 28, 2022Class II
  • K083460Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318…Apr 1, 2016Class I
  • K083460Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code #…Apr 1, 2016Class I
  • K083460Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial…Apr 1, 2016Class I
  • K083460Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can…Apr 1, 2016Class I