Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bruel & Kjaer Industri A/S · 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) |
|---|---|---|---|---|---|
| K914945 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED | Bruel & Kjaer Industri A/S | 1992-06-26 | 235 | 0 |
| K875357 | BIOPSY FIXATION UNIT-TYPE UA 0997 | Bruel & Kjaer Industri A/S | 1988-07-01 | 183 | 0 |
| K852502 | AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 | Bruel & Kjaer Industri A/S | 1986-10-23 | 498 | 0 |
| K842090 | RHINO-LARYNX STROBOSCOPE TYPE 4914 | Bruel & Kjaer Industri A/S | 1984-07-18 | 55 | 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