Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PRI · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
139 daysmedian FDA review time
207 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 | 207 | 0 |
| K192815 | Elecsys BRAHMS PCT | Roche Diagnostics | 2020-03-09 | 160 | 0 |
| K173927 | Elecsys BRAHMS PCT | Roche Diagnostics | 2018-07-06 | 192 | 0 |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN | DiaSorin, Inc. | 2018-02-27 | 88 | 0 |
| K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumip | Fujirebio Diagnostics,Inc. | 2017-12-10 | 93 | 0 |
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibra | Fisher Diagnostics | 2017-06-01 | 90 | 0 |
| K171338 | B R A H M S PCT sensitive KRYPTOR | Brahms GmbH | 2017-05-31 | 23 | 0 |
| K162827 | VIDAS B.R.A.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017-02-23 | 139 | 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