Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emerald 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) |
|---|---|---|---|---|---|
| K030483 | SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES | Emerald Medical, Inc. | 2003-03-06 | 20 | 0 |
| K030484 | SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES | Emerald Medical, Inc. | 2003-03-06 | 20 | 0 |
| K964919 | EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM | Emerald Medical, Inc. | 1997-01-28 | 50 | 0 |
| K961581 | EMERALD STERILE GAUZE SPONGE | Emerald Medical, Inc. | 1996-05-28 | 34 | 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