Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cd Leycom BV — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031599 | CD LEYCOM PRESSURE/VOLUME CATHETERS | Cd Leycom BV | 2003-12-09 | 202 | 0 |
| K030524 | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPA | Cd Leycom BV | 2003-03-03 | 12 | 0 |
| K003020 | CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / | Cd Leycom BV | 2001-05-11 | 226 | 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