Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DNK · 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) |
|---|---|---|---|---|---|
| K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine | Nantong Egens Biotech Co., Ltd. | 2015-07-16 | 36 | 0 |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2015-04-07 | 28 | 0 |
| K970579 | ONE STEP MORPHINE CARD TEST | Teco Diagnostics | 1997-07-03 | 139 | 0 |
| K853140 | MDI QUIK TEST NARCOTICS DRUG SCREEN | Medical Diagnostics, Ca. | 1986-03-03 | 217 | 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