Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MDC Research , Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022959 | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 | MDC Research , Ltd. | 2003-02-05 | 152 | 0 |
| K973012 | MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM | MDC Research , Ltd. | 1997-11-05 | 84 | 0 |
| K960013 | MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM | MDC Research , Ltd. | 1996-02-13 | 42 | 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