Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantrx Biomedical Corporation · 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) |
|---|---|---|---|---|---|
| K080436 | RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 90 | Quantrx Biomedical Corporation | 2009-02-11 | 358 | 0 |
| K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH | Quantrx Biomedical Corporation | 2009-01-08 | 324 | 0 |
| K080455 | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, | Quantrx Biomedical Corporation | 2008-12-31 | 315 | 0 |
| K070484 | QUANTRX FEMALE FERTILITY TEST | Quantrx Biomedical Corporation | 2007-10-22 | 244 | 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