510(k) Report

FDA applicant

Bc Group International, Inc.

Oak Grove, MN2 decisions2011–20151 recall

FDA records 2 decisions for Bc Group International, Inc. (Oak Grove, MN) from 2011 to 2015: 2 510(k) clearances. All are in product code DRL (Tester, Defibrillator). Its devices cite 2 predicates, 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 Bc Group International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12015: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Bc Group International, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bc Group International, Inc.’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?

  • DRLTester, Defibrillator2decisions

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 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.

  • K110192Defibrillator Analyzer - DA-2006PBc Group International, Inc. · 20111cites it

What has FDA decided for it lately?

  • K153210Defibrillator Analyzer Variable LoadBc Group International, Inc. · 2015
  • K110192Defibrillator Analyzer - DA-2006PBc Group International, Inc. · 20111 recall

All 2 as Bc Group International, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110192DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output…Oct 28, 2015Class III