Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Drug Detection Devices, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
117 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000452 | SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMI | Drug Detection Devices, Ltd. | 2000-04-24 | 73 | 0 |
| K000400 | SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST | Drug Detection Devices, Ltd. | 2000-04-18 | 71 | 0 |
| K000402 | SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLI | Drug Detection Devices, Ltd. | 2000-04-18 | 71 | 0 |
| K000522 | SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST | Drug Detection Devices, Ltd. | 2000-04-18 | 62 | 0 |
| K000350 | SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST | Drug Detection Devices, Ltd. | 2000-04-11 | 68 | 0 |
| K000449 | SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODI | Drug Detection Devices, Ltd. | 2000-04-07 | 56 | 0 |
| K000273 | SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST | Drug Detection Devices, Ltd. | 2000-04-07 | 70 | 0 |
| K992949 | SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST | Drug Detection Devices, Ltd. | 1999-12-27 | 117 | 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