510(k) Report

FDA applicant

European Custom Manufacturing BV

Gemert, NL2 decisions2004–20081 recall

FDA records 2 decisions for European Custom Manufacturing BV (Gemert, NL) from 2004 to 2008: 2 510(k) clearances. Most are in product codes LDF (Electrode, Pacemaker, Temporary) and DSA (Cable, Transducer And Electrode, Patient…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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 European Custom Manufacturing BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — European Custom Manufacturing BV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like European Custom Manufacturing BV’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?

  • LDFElectrode, Pacemaker, Temporary1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K080621Fastlock, Model PC175M01, PC175MCE, PC005R01European Custom Manufacturing BV · 20081cites it

What has FDA decided for it lately?

  • K080621Fastlock, Model PC175M01, PC175MCE, PC005R01European Custom Manufacturing BV · 2008
  • K033858Temporary Bipolar Myocardial Pacing WireEuropean Custom Manufacturing BV · 20041 recall

All 2 as European Custom Manufacturing BV →

What has been recalled?

1 recall linked to its devices; the latest:

  • K033858Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use…Apr 18, 2011