Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DIW · 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) |
|---|---|---|---|---|---|
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 | 63 | 0 |
| K930845 | ROCHE ABUSCREEN ONTRAK FOR METHADONE | Roche Diagnostic Systems, Inc. | 1993-04-20 | 61 | 0 |
| K801509 | HI-M-TEST FOR METHADONE TEST #2 | Technam, Inc. | 1980-07-14 | 14 | 0 |
| K760075 | KIT, METHADONE (TOXI-PAK IMMUNO HI) | J.T. Baker Chemical Co. | 1976-07-20 | 32 | 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