Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bicore Monitoring Systems · 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) |
|---|---|---|---|---|---|
| K935788 | BICORE SMARTCATH INTRATRACHEAL CATHETER | Bicore Monitoring Systems | 1995-07-03 | 574 | 0 |
| K921717 | BICORE SMARTVALVE OCCLUSION VALVE | Bicore Monitoring Systems | 1992-11-06 | 211 | 0 |
| K900696 | BIORE CP-100 CARDIOPULMONARY MONITOR | Bicore Monitoring Systems | 1990-11-29 | 289 | 0 |
| K896718 | BICORE VARIFLEX(R) FLOW TRANSDUCER | Bicore Monitoring Systems | 1990-02-22 | 85 | 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