510(k) Report

FDA applicant

Medtronic Heart Valves

Minneapolis, MN4 decisions1979–20060 recalls

FDA records 4 decisions for Medtronic Heart Valves (Minneapolis, MN) from 1979 to 2006: 3 510(k) clearances and 1 original PMA approval. Most are in product codes KRH (Ring, Annuloplasty) and LWR (Heart-Valve, Non-Allograft Tissue). Its devices cite 3 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 Medtronic Heart Valves’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Heart Valves since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medtronic Heart Valves 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?

  • KRHRing, Annuloplasty3decisions
  • LWRHeart-Valve, Non-Allograft Tissue1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K032810Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R)…Medtronic Heart Valves · 20032cite it
  • K052860CG Future Annuloplasty BandMedtronic Heart Valves · 20052cite it
  • K052970Simplici-T Annuloplasty SystemMedtronic Heart Valves · 20061cites it

What has FDA decided for it lately?

  • K052970Simplici-T Annuloplasty SystemMedtronic Heart Valves · 2006
  • K052860CG Future Annuloplasty BandMedtronic Heart Valves · 2005
  • K032810Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R)…Medtronic Heart Valves · 2003
  • P790007Hancock Modified Orifice BioprosthesisMedtronic Heart Valves · 1979

All 4 as Medtronic Heart Valves →