Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PMT · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
353 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | Ortho Clinical Diagnostics | 2020-02-25 | 26 | 0 |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 | 91 | 0 |
| K160911 | VIDAS B.R.A.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016-06-28 | 88 | 0 |
| K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | Roche Diagnostics | 2016-06-13 | 89 | 0 |
| DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTOR | Brahms GmbH | 2016-02-20 | 353 | 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