Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Del Medical, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223550 | DMX | Del Medical, Inc. | 2023-04-10 | 136 | 0 |
| K173018 | MDR17 Mobile Direct Radiographic System | Del Medical, Inc. | 2017-11-20 | 53 | 0 |
| K152767 | OTC12D AUTO RADIOGRAPHIC SYSTEM | Del Medical, Inc. | 2015-12-14 | 81 | 0 |
| K140825 | DELWORKS DR SYSTEM | Del Medical, Inc. | 2014-07-17 | 107 | 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