Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emi Therapy Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
19 daysmedian FDA review time
109 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K781084 | THERAPAX 150A | Emi Therapy Systems, Inc. | 1978-07-18 | 19 | 0 |
| K780948 | SYSTEM, PLANNING, TREATMENT | Emi Therapy Systems, Inc. | 1978-06-22 | 13 | 0 |
| K780027 | ACCELERATOR, LINEAR, MED. | Emi Therapy Systems, Inc. | 1978-01-26 | 22 | 0 |
| K771817 | EMI THERAPY SIMULATOR | Emi Therapy Systems, Inc. | 1978-01-13 | 109 | 0 |
| K771902 | EMI FOUR | Emi Therapy Systems, Inc. | 1977-10-19 | 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