Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bruel & Kjaer · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925484 | CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 | Bruel & Kjaer | 1993-06-22 | 235 | 0 |
| K914295 | ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED | Bruel & Kjaer | 1992-04-10 | 214 | 0 |
| K905198 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 | Bruel & Kjaer | 1991-08-28 | 281 | 0 |
| K911348 | RIGID ENDOSCOPE | Bruel & Kjaer | 1991-06-21 | 86 | 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