510(k) Report

FDA applicant

Medamicus, Inc.

Minneapolis, MN20 decisions1989–20041 recall

FDA records 20 decisions for Medamicus, Inc. (Minneapolis, MN) from 1989 to 2004: 20 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and FEN (Device, Cystometric, Hydraulic). Its devices cite 15 predicates, 11 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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Medamicus, Inc. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medamicus, 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?

  • DYBIntroducer, Catheter14decisions
  • FENDevice, Cystometric, Hydraulic3decisions
  • GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2decisions
  • DXOTransducer, Pressure, Catheter Tip1decision

Whose devices does it build on?

Its devices cite 15 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 11 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.

  • K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 20045cite it
  • K011085Guidewire Introducer Safety NeedleMedamicus, Inc. · 20014cite it
  • K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetMedamicus, Inc. · 19994cite it
  • K000824Percutaneous Introducer, Model 10383-XXXMedamicus, Inc. · 20002cite it
  • K965167Percutaneous Venous Introducer 10264Medamicus, Inc. · 19972cite it
  • K020563Medamicus Axia RSNMedamicus, Inc. · 20022cite it

What has FDA decided for it lately?

  • K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
  • K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
  • K022689Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
  • K021004Valved Peelable IntroducerMedamicus, Inc. · 2002
  • K020563Medamicus Axia RSNMedamicus, Inc. · 2002
  • K013120Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18Medamicus, Inc. · 2002
  • K011085Guidewire Introducer Safety NeedleMedamicus, Inc. · 2001
  • K000824Percutaneous Introducer, Model 10383-XXXMedamicus, Inc. · 2000

All 20 as Medamicus, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K990705Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order…Apr 28, 2014Class II