Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corscience GmbH & Co. KG — 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) |
|---|---|---|---|---|---|
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020-12-30 | 411 | 0 |
| K112077 | HBIDB - HUMAN BRIAN INDEX SOFTWARE | Corscience GmbH & Co. KG | 2012-03-09 | 232 | 0 |
| K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008-09-02 | 41 | 0 |
| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | 2008-02-28 | 71 | 1 |
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