Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Prometheus Group — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
346 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, Q | The Prometheus Group | 2016-04-15 | 23 | 0 |
| K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | The Prometheus Group | 2003-05-23 | 137 | 0 |
| K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | The Prometheus Group | 2003-02-19 | 89 | 0 |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY | The Prometheus Group | 2000-07-31 | 76 | 0 |
| K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL E | The Prometheus Group | 2000-02-22 | 90 | 0 |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | The Prometheus Group | 1997-12-22 | 59 | 0 |
| K973537 | PATHWAY ELECTROMYOGRAPH | The Prometheus Group | 1997-12-17 | 90 | 0 |
| K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/M | The Prometheus Group | 1997-01-16 | 346 | 0 |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | The Prometheus Group | 1996-08-07 | 163 | 0 |
| K960762 | SYNERGY PLUS | The Prometheus Group | 1996-06-13 | 108 | 0 |
| K897132 | PATHWAY II ELECTROMYOGRAPH | The Prometheus Group | 1991-04-18 | 477 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda