510(k) Report

FDA applicant

Biancamed Limited

Belfield, Dublin, IE1 decision2011–20110 recalls

FDA records 1 decision for Biancamed Limited (Belfield, Dublin, IE) in 2011: 1 510(k) clearance. All are in product code BZQ (Monitor, Breathing Frequency). Its devices cite 2 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, anesthesiology panel, where it files most

How often FDA has decided Biancamed Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

Planning a device like Biancamed Limited’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?

  • BZQMonitor, Breathing Frequency1decision

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.

  • K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited · 20111cites it

What has FDA decided for it lately?

  • K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited · 2011

The one decision as Biancamed Limited →