Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedical Design Instruments — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883911 | ELECTRO-ACUSCOPE 85 | Biomedical Design Instruments | 1990-02-02 | 505 | 0 |
| K833928 | MYOPULSE | Biomedical Design Instruments | 1984-12-14 | 396 | 0 |
| K833927 | ELECTRO-MYOSCOPE 85 | Biomedical Design Instruments | 1983-12-27 | 43 | 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