The Prometheus Group
Dover, NH, US
THE PROMETHEUS GROUP appears in FDA device records in Dover, NH. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for The Prometheus Group between 1991 and 2016. The busiest year on record is 1997, with 3. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1996 | 2 |
| 1997 | 3 |
| 2000 | 2 |
| 2003 | 2 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | IYO | Substantially Equivalent | |
| K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | KPI | Substantially Equivalent | |
| K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | KPI | Substantially Equivalent | |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | KPI | Substantially Equivalent | |
| K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | KPI | Substantially Equivalent | |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | HIR | Substantially Equivalent | |
| K973537 | PATHWAY ELECTROMYOGRAPH | HCC | Substantially Equivalent | |
| K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 | HIR | Substantially Equivalent | |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | HCC | Substantially Equivalent | |
| K960762 | SYNERGY PLUS | HCC | Substantially Equivalent | |
| K897132 | PATHWAY II ELECTROMYOGRAPH | HCC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1224842 | 1000513601 | THE PROMETHEUS GROUP | 1 WASHINGTON ST., SUITE 3171, DOVER, NH 03820 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain