Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Worldwide Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
383 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020869 | FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) | Worldwide Medical Corp. | 2002-06-11 | 85 | 0 |
| K993852 | FIRST CHECK HOME DRUG TEST PANEL 4 | Worldwide Medical Corp. | 2000-11-29 | 383 | 0 |
| K994139 | FIRST CHECK HOME DRUG TEST PANEL 2 | Worldwide Medical Corp. | 2000-06-23 | 199 | 0 |
| K993663 | FIRST CHECK HOME DRUG TEST (THC) | Worldwide Medical Corp. | 2000-06-23 | 238 | 0 |
| K994138 | FIRST CHECK HOME DRUG TEST PANEL 3 | Worldwide Medical Corp. | 2000-06-23 | 199 | 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