Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bruel & Kjaer Instruments, Inc. — 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) |
|---|---|---|---|---|---|
| K901881 | VIBROMETRY SYSTEM | Bruel & Kjaer Instruments, Inc. | 1991-05-31 | 400 | 0 |
| K890446 | ANESTHETIC GAS MONITOR | Bruel & Kjaer Instruments, Inc. | 1989-08-11 | 196 | 0 |
| K827409 | REAL TIME ULTRASOUND SCANNER 1849 | Bruel & Kjaer Instruments, Inc. | 1982-07-09 | 70 | 0 |
| K827380 | SCANNER TYPE 1846 | Bruel & Kjaer Instruments, Inc. | 1982-07-09 | 80 | 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