Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PEX · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
231 daysmedian FDA review time
271 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | Bruker Daltonik GmbH | 2017-07-26 | 222 | 0 |
| K162950 | VITEK MS | bioMerieux, Inc. | 2017-07-22 | 271 | 0 |
| K142677 | MALDI Biotyper CA System | Bruker Daltonics, Inc. | 2015-03-27 | 189 | 0 |
| K130831 | MALDI BIOTYPER CA (MBT-CA) SYSTEM | Bruker Daltonics, Inc. | 2013-11-21 | 240 | 0 |
| DEN130013 | VITEK MS | bioMerieux, Inc. | 2013-08-21 | 231 | 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