The Prometheus Group: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “The Prometheus Group” (first 1991, latest 2016), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 23 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HCC | Device, Biofeedback | 4 | 4 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 4 | 4 |
| HIR | Perineometer | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Gastroenterology and Urology (6)
- Neurology (4)
- Radiology (1)
Most recent The Prometheus Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | IYO | 2016-04-15 | 23 |
| K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | KPI | 2003-05-23 | 137 |
| K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | KPI | 2003-02-19 | 89 |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | KPI | 2000-07-31 | 76 |
| K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | KPI | 2000-02-22 | 90 |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | HIR | 1997-12-22 | 59 |
| K973537 | PATHWAY ELECTROMYOGRAPH | HCC | 1997-12-17 | 90 |
| K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 | HIR | 1997-01-16 | 346 |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | HCC | 1996-08-07 | 163 |
| K960762 | SYNERGY PLUS | HCC | 1996-06-13 | 108 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Prometheus Group.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under The Prometheus Group (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Prometheus Group?
FDA lists 11 510(k) clearances under the applicant name “The Prometheus Group” (first 1991, latest 2016), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Prometheus Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Prometheus Group is 90 days.
Which FDA product codes appear under The Prometheus Group?
The most frequent FDA product codes under this applicant name are HCC (Device, Biofeedback, 4); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 4); HIR (Perineometer, 2).
Next steps
- See all 11 The Prometheus Group clearances with predicates and recalls
- Run predicate analysis for product code HCC, The Prometheus Group's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.