Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Myo-Tronics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
841 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | Myo-Tronics, Inc. | 1997-04-02 | 79 | 0 |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Myo-Tronics, Inc. | 1994-12-09 | 107 | 0 |
| K922270 | PHYSIOTECH 4000 OR NORODYN 8000 | Myo-Tronics, Inc. | 1994-09-02 | 841 | 0 |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | 1994-06-09 | 744 | 0 |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | 1993-01-07 | 259 | 0 |
| K905449 | ELECTROSONOGRAM ESG-1 | Myo-Tronics, Inc. | 1991-04-26 | 142 | 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