510(k) Report

FDA applicant

Lifebridge Medizintechnik AG

Bryn Mawr, PA3 decisions2009–20110 recalls

FDA records 3 decisions for Lifebridge Medizintechnik AG (Bryn Mawr, PA) from 2009 to 2011: 3 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and DTQ (Console, Heart-Lung Machine, Cardiopulmonary…). Its devices cite 9 predicates, 2 of them its own earlier devices. No 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 Lifebridge Medizintechnik AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12010: 12011: 1
2009high 1 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Lifebridge Medizintechnik AG by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lifebridge Medizintechnik 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?

  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2decisions
  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 20093cite it

What has FDA decided for it lately?

  • K111384LifebridgeLifebridge Medizintechnik AG · 2011
  • K103357LifebridgeLifebridge Medizintechnik AG · 2010
  • K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009

All 3 as Lifebridge Medizintechnik AG →