Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LAO — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
261 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024-02-20 | 123 | 0 |
| K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | 2023-12-20 | 166 | 0 |
| K163359 | ARK Methotrexate Assay | Ark Diagnostics, Inc. | 2017-08-18 | 261 | 0 |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK MET | Ark Diagnostics, Inc. | 2011-10-18 | 105 | 0 |
| K932615 | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | Abbott Laboratories | 1993-07-14 | 43 | 1 |
| K884744 | ACA DU PONT METHOTREXATE (MTHO) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1989-01-30 | 77 | 0 |
| K833634 | EMIT & METHOFREXATE ASSAY | Syva Co. | 1983-12-22 | 66 | 0 |
| K830398 | TDX METHOTREXATE | Abbott Laboratories | 1983-03-10 | 31 | 0 |
| K811459 | EMIT-AND METHOTREXATE ASSAY | Syva Co. | 1981-06-09 | 14 | 1 |
| K781381 | EMIT METHATREXATE ASSAY | Dade Behring, Inc. | 1978-10-10 | 60 | 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