Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio Control BV — 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) |
|---|---|---|---|---|---|
| K962854 | HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFT | Cardio Control BV | 1997-01-27 | 189 | 0 |
| K935732 | CARDIO PERFECT ST 2001 | Cardio Control BV | 1996-04-04 | 855 | 0 |
| K922898 | CARDIO PERFECT, CARDIO PERFECT MD | Cardio Control BV | 1993-11-01 | 503 | 0 |
| K913374 | CARDIO PERFECT, CARDIO PERFECT MD | Cardio Control BV | 1992-01-23 | 178 | 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