Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Myotronics-Noromed, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
154 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111687 | EMG SYSTEM | Myotronics-Noromed, Inc. | 2011-09-29 | 105 | 0 |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | Myotronics-Noromed, Inc. | 2004-07-20 | 154 | 0 |
| K031998 | MODEL J-5 MVO-MONITOR | Myotronics-Noromed, Inc. | 2003-07-24 | 27 | 0 |
| K013399 | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | 2001-11-13 | 29 | 0 |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | 2000-11-06 | 17 | 0 |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Myotronics-Noromed, Inc. | 1999-09-10 | 29 | 0 |
| K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 | Myotronics-Noromed, Inc. | 1999-08-13 | 22 | 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