Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Myo-Tronics Research, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
167 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842224 | BNS 40 | Myo-Tronics Research, Inc. | 1984-11-19 | 167 | 0 |
| K842223 | J4 MYO-MONITOR | Myo-Tronics Research, Inc. | 1984-11-19 | 167 | 0 |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. | 1984-02-10 | 150 | 0 |
| K831364 | TESTCORP RA | Myo-Tronics Research, Inc. | 1983-05-27 | 31 | 0 |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Myo-Tronics Research, Inc. | 1983-02-09 | 33 | 0 |
| K813533 | ELECTRIC MUSCLE STIMULATOR | Myo-Tronics Research, Inc. | 1982-03-05 | 78 | 0 |
| K810528 | MODEL EM-IR | Myo-Tronics Research, Inc. | 1981-03-31 | 33 | 0 |
| K770252 | MONITOR, MYO, MODEL J3 | Myo-Tronics Research, Inc. | 1977-02-18 | 9 | 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