510(k) Report

FDA applicant

Novalung GmbH

North Attleboro, MA2 decisions2007–20110 recalls

FDA records 2 decisions for Novalung GmbH (North Attleboro, MA) from 2007 to 2011: 2 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 3 predicates, 0 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 Novalung GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DTZOxygenator, Cardiopulmonary Bypass1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K072362Novalung Surgical Lung Assist (Sla) Membrane LungNovalung GmbH · 20072cite it

What has FDA decided for it lately?

  • K112565Novaport One Vascular Access CannulaNovalung GmbH · 2011
  • K072362Novalung Surgical Lung Assist (Sla) Membrane LungNovalung GmbH · 2007

All 2 as Novalung GmbH →