Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NRP — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
212 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083487 | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETR | Siemens Healthcare Diagnostics | 2009-03-30 | 125 | 0 |
| K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMU | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 | 121 | 1 |
| K070822 | ARCHITECT SIROLIMUS ASSAY | Fujirebio Diagnostics,Inc. | 2007-09-28 | 186 | 1 |
| K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | Axis-Shield , Ltd. | 2005-04-07 | 212 | 2 |
| DEN040008 | CEDIA SIROLIMUS ASSAY | Microgenics Corp. | 2004-07-28 | 41 | 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