510(k) Report

FDA applicant

Links Medical Products, Inc.

Laguna Niguel, CA4 decisions2012–20141 recall

FDA records 4 decisions for Links Medical Products, Inc. (Laguna Niguel, CA) from 2012 to 2014: 4 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 6 predicates, 2 of them its own earlier devices. 1 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 Links Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2012: 22014: 2
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2012high 1 (2023) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Links Medical Products, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • FRODressing, Wound, Drug4decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K121227Manuka FillLinks Medical Products, Inc. · 20121cites it
  • K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 20141cites it
  • K120976Manuka IGLinks Medical Products, Inc. · 20121cites it

What has FDA decided for it lately?

  • K133934Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with Silicone Adhesive Border)Links Medical Products, Inc. · 2014
  • K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 20141 recall
  • K121227Manuka FillLinks Medical Products, Inc. · 2012
  • K120976Manuka IGLinks Medical Products, Inc. · 2012

All 4 as Links Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K131796MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF…May 3, 2023Class II