Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MVO · Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
153 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040327 | ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJU | Accu-Stat Diagnostics, Inc. | 2004-04-19 | 69 | 0 |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Phamatech | 2003-04-14 | 62 | 0 |
| K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK M | Princeton BioMeditech Corp. | 2002-05-23 | 153 | 0 |
| K013778 | PEACE OF MIND HOME DRUG TEST | Advantage Diagnostics Corp. | 2002-02-07 | 86 | 0 |
| K013409 | AT HOME DRUG TEST, MODEL 9074 | Phamatech, Inc. | 2001-12-06 | 52 | 0 |
| K013410 | AT HOME DRUG TEST, MODEL 9064 | Phamatech, Inc. | 2001-12-06 | 52 | 0 |
| K013412 | AT HOME DRUG TEST, MODEL 9069 | Phamatech, Inc. | 2001-12-06 | 52 | 0 |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | Phamatech | 2001-04-05 | 31 | 0 |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Phamatech | 2001-04-05 | 31 | 0 |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | Phamatech | 2001-04-05 | 31 | 0 |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Phamatech | 2001-03-30 | 25 | 0 |
| K003858 | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 91 | Phamatech | 2001-02-12 | 61 | 0 |
| K991465 | DRUG STOP | Texas Immunology, Inc. | 1999-12-10 | 227 | 0 |
| K992685 | QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C | Phamatech | 1999-10-06 | 57 | 0 |
| K992217 | AT HOME DRUG TEST, MODEL 9175 | Phamatech | 1999-07-13 | 12 | 0 |
| K991824 | AT HOME DRUG TEST, MODEL 9171 | Phamatech | 1999-06-11 | 15 | 0 |
| K991641 | AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 | Phamatech | 1999-06-01 | 20 | 0 |
| K982621 | QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 | Phamatech | 1998-10-16 | 80 | 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