Data / Medical devices / United States / The Prometheus Group
The Prometheus Group: FDA-registered device maker in Dover, NH, United States, 8 510(k) clearances
The Prometheus Group is registered with the FDA (registration 1224842) in Dover, NH, United States. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 15, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1224842
- FEI number
- 1000513601
- Address
- 1 Washington ST., Suite 3171, Dover, NH, United States, 03820
- Owner or operator
- THE PROMETHEUS GROUP (9021632)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 28, 1995
- Registered through
- 2026
- Brand names listed
- Pathway MR-10, MR-15, MR-20, MR-25, Pathway STM-10 Pelvic Floor Stimulator, Pathway TR-10, TR-10C, TR-20, TR-20C, Pathway Vaginal/Rectal Perineometer Probe, Synergy 3D, Telesis, Telesis-ST, Primus, Synergy Plus, VARIOUS MODELS OF SUR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
| Uroflowmeter | EXY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2016 | K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | IYO | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| May 23, 2003 | K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | KPI | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| February 19, 2003 | K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | KPI | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| February 22, 2000 | K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | KPI | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| December 22, 1997 | K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | HIR | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| December 17, 1997 | K973537 | PATHWAY ELECTROMYOGRAPH | HCC | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| January 16, 1997 | K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 | HIR | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
| June 13, 1996 | K960762 | SYNERGY PLUS | HCC | Substantially Equivalent | The Prometheus Group | accessdata.fda.gov |
Compare with other makers
- All makers of Perineometer
- All makers of Device, Biofeedback
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Uroflowmeter
Updated April 15, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.