510(k) Report

FDA applicant

Mayo Clinic

Rochester, MN3 decisions1985–20040 recalls

FDA records 3 decisions for Mayo Clinic (Rochester, MN) from 1985 to 2004: 3 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and HAW (Neurological Stereotaxic Instrument). 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, orthopedic panel, where it files most

How often FDA has decided Mayo Clinic’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mayo Clinic since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mayo Clinic 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?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision
  • HAWNeurological Stereotaxic Instrument1decision
  • MOSCoil, Magnetic Resonance, Specialty1decision

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.

  • K943230Mayo Hip ProsthesisMayo Clinic · 19974cite it

What has FDA decided for it lately?

  • K040122Mayo Clinic BC-10 3.0TMayo Clinic · 2004
  • K943230Mayo Hip ProsthesisMayo Clinic · 1997
  • K852477Kelly-Groerss-Kall CT Sterotactic Adaptation SysMayo Clinic · 1985

All 3 as Mayo Clinic →

Other applicant names beginning “Mayo”

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

Mayo Medical Ventures 1