510(k) Report

FDA applicant

VBM Medizintechnik GmbH

Baden-Wurttemberg, DE3 decisions1997–20203 recalls

FDA records 3 decisions for VBM Medizintechnik GmbH (Baden-Wurttemberg, DE) from 1997 to 2020: 3 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

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

How often FDA has decided VBM Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12020: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2011

2009: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like VBM Medizintechnik GmbH’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?

  • BTLVentilator, Emergency, Powered (Resuscitator)1decision
  • BTOTube, Tracheostomy (W/Wo Connector)1decision
  • BWCNeedle, Emergency Airway1decision

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.

  • K112783Manujet IiiVBM Medizintechnik GmbH · 20111cites it

What has FDA decided for it lately?

  • K200190ScalpelCricVBM Medizintechnik GmbH · 2020
  • K112783Manujet IiiVBM Medizintechnik GmbH · 2011
  • K955461Transtracheal Catheter (Acc. Ravussin).VBM Medizintechnik GmbH · 19973 recalls

All 3 as VBM Medizintechnik GmbH →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K955461Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM…May 9, 2011
  • K955461Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM…May 9, 2011
  • K955461Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The…Jul 9, 2009