510(k) Report

FDA applicant

Bracco Injeneering

Lausanne, CH2 decisions2014–20160 recalls

FDA records 2 decisions for Bracco Injeneering (Lausanne, CH) from 2014 to 2016: 2 510(k) clearances. Most are in product codes IZQ (Injector, Contrast Medium, Automatic) and PQH (Iodinated Contrast Media Transfer Tubing Set). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bracco Injeneering S.A.”.

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

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

How often FDA has decided Bracco Injeneering’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Bracco Injeneering by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bracco Injeneering’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?

  • IZQInjector, Contrast Medium, Automatic1decision
  • PQHIodinated Contrast Media Transfer Tubing Set1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetBracco Injeneering · 20162cite it
  • K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 20142cite it

What has FDA decided for it lately?

  • K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetBracco Injeneering · 2016
  • K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014

The one decision as Bracco Injeneering →The one decision as Bracco Injeneering S.A. →

Other applicant names beginning “Bracco”

FDA records each applicant name separately; these may or may not be the same firm.

Bracco Diagnostic, Inc. 3Bracco Diagnostics, Inc. 2