510(k) Report

FDA applicant

Manuka Medical Limited

Laguna Niguel, CA3 decisions2010–20110 recalls

FDA records 3 decisions for Manuka Medical Limited (Laguna Niguel, CA) from 2010 to 2011: 3 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 5 predicates, 3 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

How often FDA has decided Manuka Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 22011: 1
2010high 2 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Manuka Medical Limited by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K092689Manukapli Wound DressingManuka Medical Limited · 20104cite it
  • K110042ManukatexManuka Medical Limited · 20111cites it
  • K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 20101cites it

What has FDA decided for it lately?

  • K110042ManukatexManuka Medical Limited · 2011
  • K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010
  • K092689Manukapli Wound DressingManuka Medical Limited · 2010

All 3 as Manuka Medical Limited →

Other applicant names beginning “Manuka”

FDA records each applicant name separately; these may or may not be the same firm.

Manuka Health New Zealand, Ltd. 1