Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siegen Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
152 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871964 | SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU. | Siegen Corp. | 1987-10-01 | 134 | 0 |
| K861884 | NEUROSCOPE SEEG | Siegen Corp. | 1986-10-14 | 152 | 0 |
| K862430 | SIEGEN HEADPHONES | Siegen Corp. | 1986-09-26 | 92 | 0 |
| K844616 | SIEGEN VISUAL STIMULATOR | Siegen Corp. | 1985-02-14 | 79 | 0 |
| K844646 | SIEGEN SURFACE ELECTRODES | Siegen Corp. | 1984-12-11 | 12 | 0 |
| K843464 | SIEGEN NEUROSCOPE | Siegen Corp. | 1984-11-20 | 76 | 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