Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DIE · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020610 | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | Bio-Rad | 2002-04-22 | 56 | 0 |
| K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | Bio-Rad | 1999-04-16 | 28 | 0 |
| K891691 | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | Bio-Rad | 1989-12-19 | 272 | 0 |
| K890721 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Actio, Inc. | 1989-04-10 | 56 | 0 |
| K863915 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Shape Products Co. | 1986-11-24 | 47 | 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