510(k) Report

FDA applicant

Itl Corporation Pty, Ltd.

Fyshwick, Canberra Act, AU5 decisions1999–20160 recalls

FDA records 5 decisions for Itl Corporation Pty, Ltd. (Fyshwick, Canberra Act, AU) from 1999 to 2016: 5 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and HAM (Apparatus, Electrosurgical). Its devices cite 5 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Itl Corporation Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions
  • HAMApparatus, Electrosurgical1decision
  • HIBSpeculum, Vaginal, Nonmetal1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K021941Samplok Luer KitItl Corporation Pty, Ltd. · 20021cites it
  • K000777SamplokItl Corporation Pty, Ltd. · 20001cites it
  • K021017Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd. · 20021cites it

What has FDA decided for it lately?

  • K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd. · 2016
  • K021941Samplok Luer KitItl Corporation Pty, Ltd. · 2002
  • K021017Leespec Disposable Vaginal SpeculumItl Corporation Pty, Ltd. · 2002
  • K000777SamplokItl Corporation Pty, Ltd. · 2000
  • K991404Platypus AV Fistula Needle Protector (Avfnp)Itl Corporation Pty, Ltd. · 1999

All 5 as Itl Corporation Pty, Ltd. →