Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Engineering Dynamics Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
172 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871494 | UPPERCYCLE STATIONARY EXERCISE MACHINES | Engineering Dynamics Corp. | 1987-05-06 | 20 | 0 |
| K844578 | NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA | Engineering Dynamics Corp. | 1985-05-14 | 172 | 0 |
| K842108 | UNIVERSAL EXAMINATION TABLE | Engineering Dynamics Corp. | 1984-07-17 | 49 | 0 |
| K834098 | STATIONARY EXERCISE BICYCLE | Engineering Dynamics Corp. | 1983-12-27 | 29 | 0 |
| K828313 | DIGITAL RADIOGRAPHY EXAMINATION TABLE | Engineering Dynamics Corp. | 1982-10-07 | 15 | 0 |
| K802254 | GENERAL ULTRASOUND EXAM. TABLE | Engineering Dynamics Corp. | 1980-11-26 | 71 | 0 |
| K790545 | STRESS TESTING SYSTEM, LATERAL TILTING | Engineering Dynamics Corp. | 1979-06-06 | 78 | 0 |
| K790544 | STRESS TESTING SYSTEM, MULTI-POSITION | Engineering Dynamics Corp. | 1979-06-05 | 75 | 0 |
| K790466 | U-MAT | Engineering Dynamics Corp. | 1979-03-28 | 23 | 0 |
| K790499 | MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER | Engineering Dynamics Corp. | 1979-03-26 | 13 | 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