FDA applicant

ImpediMed Limited

Pinkenba, AU17 decisions2005–20261 recall

FDA records 17 decisions for ImpediMed Limited (Pinkenba, AU) from 2005 to 2026: 17 510(k) clearances. Most are in product codes OBH (Monitor, Extracellular Fluid, Lymphedema…) and DSB (Plethysmograph, Impedance). Its devices cite 21 predicates, 15 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Impedimed Pty , Ltd.”.

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 ImpediMed Limited’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2007high 3 (2023) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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ImpediMed Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?