510(k) Report

FDA applicant

Plastiflex Group NV

Claremont, NH2 decisions2010–20160 recalls

FDA records 2 decisions for Plastiflex Group NV (Claremont, NH) from 2010 to 2016: 2 510(k) clearances. All are in product code BZE (Heater, Breathing System W/Wo Controller (Not…). 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, anesthesiology panel, where it files most

How often FDA has decided Plastiflex Group NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010: 12016: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Plastiflex Group NV by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2decisions

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 4 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.

  • K100104Hybernite Rainout Control SystemPlastiflex Group NV · 20102cite it
  • K151461Hybernite RTPlastiflex Group NV · 20162cite it

What has FDA decided for it lately?

  • K151461Hybernite RTPlastiflex Group NV · 2016
  • K100104Hybernite Rainout Control SystemPlastiflex Group NV · 2010

All 2 as Plastiflex Group NV →