510(k) Report

FDA applicant

Medisize BV

Hillegom, NL4 decisions2005–20130 recalls

FDA records 4 decisions for Medisize BV (Hillegom, NL) from 2005 to 2013: 4 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 1 predicate, 1 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 Medisize BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12009: 12013: 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 — Medisize BV 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?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)3decisions
  • CAHFilter, Bacterial, Breathing-Circuit1decision

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070714Medisize Gold Heater and BoosterMedisize BV · 20071cites it

What has FDA decided for it lately?

  • K122885Medisize Gold Heater and Booster T-PieceMedisize BV · 2013
  • K081536Medisize Blue, Medisize Green, Medisize RedMedisize BV · 2009
  • K070714Medisize Gold Heater and BoosterMedisize BV · 2007
  • K052615Medisize GoldMedisize BV · 2005

All 4 as Medisize BV →