510(k) Report

FDA applicant

Buhlmann Laboratories AG

Schönenbuch, CH5 decisions1995–20240 recalls

FDA records 5 decisions for Buhlmann Laboratories AG (Schönenbuch, CH) from 1995 to 2024: 5 510(k) clearances. Most are in product codes NXO (Calprotectin, Fecal) and CIB (Radioimmunoassay, Angiotensin I And Renin). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bühlmann Laboratories AG”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Buhlmann Laboratories AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12019: 22024: 1
2007high 2 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • NXOCalprotectin, Fecal4decisions
  • CIBRadioimmunoassay, Angiotensin I And Renin1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 20191cites it
  • K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG · 20181cites it
  • K190784BUHLMANN fCAL turboBuhlmann Laboratories AG · 20191cites it

What has FDA decided for it lately?

  • K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG · 2024
  • K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019
  • K190784BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019
  • K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018
  • K954299Buhlmann Angiostensin II RiaBuhlmann Laboratories AG · 1995

All 4 as Buhlmann Laboratories AG →The one decision as Bühlmann Laboratories AG →