510(k) Report

FDA applicant

Incontrol Medical, LLC

Brookfield, WI7 decisions2012–20190 recalls

FDA records 7 decisions for Incontrol Medical, LLC (Brookfield, WI) from 2012 to 2019: 7 510(k) clearances. All are in product code KPI (Stimulator, Electrical, Non-Implantable, For…). Its devices cite 13 predicates, 9 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2019

2012: 12014: 32015: 22019: 1
2012high 3 (2014) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

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

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Which product codes does it file in?

  • KPIStimulator, Electrical, Non-Implantable, For Incontinence7decisions

Whose devices does it build on?

Its devices cite 13 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 9 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.

  • K110179IncontrolIncontrol Medical, LLC · 20127cite it
  • K134020IntonemvIncontrol Medical, LLC · 20143cite it
  • K141158APEXIncontrol Medical, LLC · 20142cite it
  • K150183ApexMIncontrol Medical, LLC · 20152cite it
  • K182022ApexMVIncontrol Medical, LLC · 20191cites it

What has FDA decided for it lately?

  • K182022ApexMVIncontrol Medical, LLC · 2019
  • K150183ApexMIncontrol Medical, LLC · 2015
  • K150180InToneIncontrol Medical, LLC · 2015
  • K141158APEXIncontrol Medical, LLC · 2014
  • K134020IntonemvIncontrol Medical, LLC · 2014
  • K133826IntonemvIncontrol Medical, LLC · 2014
  • K110179IncontrolIncontrol Medical, LLC · 2012

All 7 as Incontrol Medical, LLC →