Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IOA · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941567 | DIATHERMY DEVICE-MICROFOCUS | Cheung Laboratories, Inc. | 1996-04-22 | 752 | 0 |
| K895000 | NEMECTRON MICROWAVE | Nemectron Medical, Inc. | 1990-07-27 | 353 | 0 |
| K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | Elmed, Inc. | 1986-07-16 | 49 | 0 |
| K860082 | THERMOTRON 918 | Medical Microwave Research Corp. | 1986-03-27 | 78 | 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