510(k) Report

FDA applicant

Tuta Healthcare Pty Limited

Sydney Nsw, AU3 decisions2002–20020 recalls

FDA records 3 decisions for Tuta Healthcare Pty Limited (Sydney Nsw, AU) in 2002: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and BRZ (Set, Blood Transfusion). 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, general hospital panel, where it files most

How often FDA has decided Tuta Healthcare Pty Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tuta Healthcare Pty Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision
  • BRZSet, Blood Transfusion1decision
  • HRXArthroscope1decision

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.

  • K023595Burette-in Line (150 ML)Tuta Healthcare Pty Limited · 20023cite it
  • K023039Blood/Solution Administration Set, Model 33.015Tuta Healthcare Pty Limited · 20021cites it

What has FDA decided for it lately?

  • K023595Burette-in Line (150 ML)Tuta Healthcare Pty Limited · 2002
  • K023039Blood/Solution Administration Set, Model 33.015Tuta Healthcare Pty Limited · 2002
  • K020083Tuta Healthcare Arthroscopy Flushing Set, Model 80.601Tuta Healthcare Pty Limited · 2002

All 3 as Tuta Healthcare Pty Limited →