Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NTM · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070310 | B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM | Brahms Aktiengesellschaft | 2008-03-31 | 424 | 0 |
| K071146 | VIDAS B.R.A.H.M.S. PCT ASSAY | bioMerieux, Inc. | 2007-10-11 | 170 | 1 |
| K040887 | B-R-A-H-M-S PCT LIA | Brahms Aktiengesellschaft | 2005-01-07 | 277 | 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