510(k) Report

FDA applicant

The Prometheus Group

Duxbury, MA11 decisions1991–20160 recalls

FDA records 11 decisions for The Prometheus Group (Duxbury, MA) from 1991 to 2016: 11 510(k) clearances. Most are in product codes KPI (Stimulator, Electrical, Non-Implantable, For…) and HCC (Device, Biofeedback). Its devices cite 8 predicates, 3 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 The Prometheus Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like The Prometheus Group’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KPIStimulator, Electrical, Non-Implantable, For Incontinence4decisions
  • HCCDevice, Biofeedback4decisions
  • HIRPerineometer2decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 3 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.

  • K001515Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000The Prometheus Group · 20004cite it
  • K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 20033cite it
  • K974036Pathway Vaginal/Rectal Perineometer ProbeThe Prometheus Group · 19971cites it
  • K960508Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25The Prometheus Group · 19971cites it
  • K897132Pathway II ElectromyographThe Prometheus Group · 19911cites it

What has FDA decided for it lately?

  • K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group · 2016
  • K030039Pathway STM-10 Pelvic Floor StimulatorThe Prometheus Group · 2003
  • K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003
  • K001515Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000The Prometheus Group · 2000
  • K993976Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorThe Prometheus Group · 2000
  • K974036Pathway Vaginal/Rectal Perineometer ProbeThe Prometheus Group · 1997
  • K973537Pathway ElectromyographThe Prometheus Group · 1997
  • K960508Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25The Prometheus Group · 1997

All 11 as The Prometheus Group →