Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bühlmann Laboratories AG · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
210 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024-02-06 | 210 | 0 |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019-09-24 | 90 | 0 |
| K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019-06-25 | 90 | 0 |
| K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018-06-04 | 48 | 0 |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | Buhlmann Laboratories AG | 1995-10-19 | 35 | 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