510(k) Report

FDA applicant

Envoy Medical Corporation

St. Paul, MN2 decisions2008–20102 recalls

FDA records 2 decisions for Envoy Medical Corporation (St. Paul, MN) from 2008 to 2010: 1 510(k) clearance and 1 original PMA approval. Most are in product codes NEA (Cement, Ear, Nose And Throat) and OAF (Implant, Hearing, Active, Middle Ear, Totally…). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

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

FDA decisions per year

1in 2010

2008: 12010: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2018

2013: 12018: 1
2008high 1 (2013) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Envoy Medical Corporation by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NEACement, Ear, Nose And Throat1decision
  • OAFImplant, Hearing, Active, Middle Ear, Totally Implanted1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K080032Envoycem, Model 1640Envoy Medical Corporation · 20081cites it

What has FDA decided for it lately?

  • P090018Esteem Totally Implantable Hearing SystemEnvoy Medical Corporation · 20102 recalls
  • K080032Envoycem, Model 1640Envoy Medical Corporation · 2008

All 2 as Envoy Medical Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P090018Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001…Jun 28, 2018Class II
  • P090018Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem…Jan 9, 2013Class II