Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Scan, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
385 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003480 | BIOFIND | Bio-Scan, Inc. | 2001-05-11 | 183 | 0 |
| K925735 | EEG ANALYZER | Bio-Scan, Inc. | 1993-12-03 | 385 | 0 |
| K864928 | BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER | Bio-Scan, Inc. | 1987-03-31 | 105 | 0 |
| K841684 | BIO/SCAN BIOLOG CASSETTE RECORDER | Bio-Scan, Inc. | 1984-06-07 | 45 | 0 |
| K841683 | Q.P. PREAMPLIFIER SYS | Bio-Scan, Inc. | 1984-06-07 | 45 | 0 |
| K841685 | EEG ELECTRODES | Bio-Scan, Inc. | 1984-06-07 | 45 | 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