# The Prometheus Group

- Location (FDA's records): Duxbury, MA
- FDA decisions: 11 (1991–2016): 11 510(k) clearances
- Product codes: KPI (4), HCC (4), HIR (2), IYO (1)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hollister, Inc.: 3 (https://510kreport.com/company/hollister)
- Perrymeter Systems: 1 (https://510kreport.com/company/perrymeter-systems)
- Regulatory Management Services: 1 (https://510kreport.com/company/regulatory-management-services)

## Firms that cite its devices most
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Uroval: 1 (https://510kreport.com/company/uroval)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Athena Feminine Technologies, Inc.: 1 (https://510kreport.com/company/athena-feminine-technologies)
- Thought Technology, Ltd.: 1 (https://510kreport.com/company/thought-technology)
- Nicolet Biomedical, Inc.: 1 (https://510kreport.com/company/nicolet-biomedical)

## Its most-cited devices
- K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 (2000), cited by 4
- K023906: Pathway CTS2000 Pelvic Floor Training System (2003), cited by 3
- K974036: Pathway Vaginal/Rectal Perineometer Probe (1997), cited by 1
- K960508: Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25 (1997), cited by 1
- K897132: Pathway II Electromyograph (1991), cited by 1

## Recent decisions
- K160792: Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound (Apr 15, 2016)
- K030039: Pathway STM-10 Pelvic Floor Stimulator (May 23, 2003)
- K023906: Pathway CTS2000 Pelvic Floor Training System (Feb 19, 2003)
- K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 (Jul 31, 2000)
- K993976: Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor (Feb 22, 2000)
- K974036: Pathway Vaginal/Rectal Perineometer Probe (Dec 22, 1997)
- K973537: Pathway Electromyograph (Dec 17, 1997)
- K960508: Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25 (Jan 16, 1997)

Source page: https://510kreport.com/company/prometheus-group