Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schneider (Europe) GmbH — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984068 | FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS | Schneider (Europe) GmbH | 1999-01-07 | 52 | 0 |
| K982592 | DOCKING-EXTENSION WIRE | Schneider (Europe) GmbH | 1998-10-21 | 89 | 0 |
| K970528 | CLYDE CORONARY GUIDEWIRE | Schneider (Europe) GmbH | 1997-06-10 | 119 | 0 |
| K970494 | HANNIBAL GUIDEWIRE | Schneider (Europe) GmbH | 1997-05-09 | 88 | 0 |
| K951109 | C-THRU CORONARY GUIDE WIRE | Schneider (Europe) GmbH | 1995-06-08 | 90 | 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