510(k) Report

FDA applicant

Medical Developments International Limited

Springvale, AU2 decisions2013–20160 recalls

FDA records 2 decisions for Medical Developments International Limited (Springvale, AU) from 2013 to 2016: 2 510(k) clearances. All are in product code NVP (Holding Chambers, Direct Patient Interface). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medical Developments International”.

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 Medical Developments International Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12016: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Medical Developments International Limited by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NVPHolding Chambers, Direct Patient Interface2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K143615Antistatic Compact Space ChamberMedical Developments International Limited · 2016
  • K122252Space Chamber Plus Compact Space Chamber PlusMedical Developments International · 2013

The one decision as Medical Developments International Limited →The one decision as Medical Developments International →