Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biological Signal Processing, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
132 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102579 | HYPERQ AD-100 SYSTEM | Biological Signal Processing, Ltd. | 2010-12-02 | 85 | 0 |
| K082564 | HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2008-10-20 | 46 | 0 |
| K072389 | MODIFICATION TO HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2007-09-18 | 25 | 0 |
| K070624 | HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2007-04-06 | 31 | 0 |
| K042981 | HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2005-03-10 | 132 | 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