Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NFW · 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) |
|---|---|---|---|---|---|
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Acc | Healgen Scientific,, LLC | 2026-02-12 | 185 | 0 |
| K231978 | BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 | 59 | 0 |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Stri | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 | 28 | 0 |
| K191924 | SAFECARE® THC Urine Strip Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2019-08-16 | 29 | 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