510(k) Report

FDA applicant

Admedus Regen Pty, Ltd.

Malaga, AU3 decisions2016–20200 recalls

FDA records 3 decisions for Admedus Regen Pty, Ltd. (Malaga, AU) from 2016 to 2020: 3 510(k) clearances. Most are in product codes PSQ (Intracardiac Patch Or Pledget, Biologically…) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 4 predicates, 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, cardiovascular panel, where it files most

How often FDA has decided Admedus Regen Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12017: 12020: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Admedus Regen Pty, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PSQIntracardiac Patch Or Pledget, Biologically Derived2decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162579VascuCelAdmedus Regen Pty, Ltd. · 20161cites it

What has FDA decided for it lately?

  • K200566ADAPT TissueAdmedus Regen Pty, Ltd. · 2020
  • K170951CardioCel 3DAdmedus Regen Pty, Ltd. · 2017
  • K162579VascuCelAdmedus Regen Pty, Ltd. · 2016

All 3 as Admedus Regen Pty, Ltd. →