Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dynatronics Laser Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
371 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920939 | DYNATRON 300 ULRASOUND | Dynatronics Laser Corp. | 1993-03-04 | 371 | 0 |
| K900639 | DYNATRON 350 EMG/BIOFEEDBACK ANALYZER | Dynatronics Laser Corp. | 1990-10-04 | 237 | 0 |
| K900321 | DYNATRON 330 BODY COMPOSITION ANALYZER | Dynatronics Laser Corp. | 1990-06-11 | 139 | 0 |
| K880464 | DYNATRON II | Dynatronics Laser Corp. | 1988-03-08 | 34 | 0 |
| K864370 | DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR) | Dynatronics Laser Corp. | 1987-04-10 | 156 | 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