Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LNW · 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) |
|---|---|---|---|---|---|
| K032161 | PHEM-ALERT | Femtek,Llc. | 2003-09-30 | 77 | 0 |
| K012230 | PHEM-ALERT | Femtek,Llc. | 2001-10-09 | 85 | 0 |
| K960648 | PHEM-CHEK | Femtek, Inc. | 1996-05-13 | 89 | 0 |
| K850858 | OB-PH - PH TEST PAPER | Uro Pharmaceuticals, Inc. | 1985-05-24 | 84 | 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