Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QBN — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251495 | MBT Compass HT CA Software; MBT FAST Shuttle US IVD | Bruker Daltonics GmbH & Co. KG | 2025-08-13 | 90 | 0 |
| K212461 | VITEK MS PRIME | bioMerieux, Inc. | 2022-03-15 | 221 | 0 |
| K181412 | VITEK MS | bioMerieux, Inc. | 2018-12-21 | 205 | 0 |
| DEN170081 | MALDI Biotyper CA System | Bruker Daltonik GmbH | 2018-04-20 | 203 | 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