Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Madsen Electronics, 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) |
|---|---|---|---|---|---|
| K002200 | CAPELLA | Madsen Electronics, Inc. | 2000-08-25 | 36 | 0 |
| K983851 | CAPELLA COCHLEAR EMISSIONS ANALYZER | Madsen Electronics, Inc. | 1999-01-28 | 90 | 0 |
| K945199 | RH2000 REAL EAR MEASUREMENT SYSTEM | Madsen Electronics, Inc. | 1995-04-11 | 169 | 0 |
| K945032 | VOYAGER 522 | Madsen Electronics, Inc. | 1995-02-02 | 112 | 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