Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocardia, Inc. · 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) |
|---|---|---|---|---|---|
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. | 2019-05-06 | 26 | 0 |
| K090999 | BIOCARDIA MORPH SHEATH GUIDE | Biocardia, Inc. | 2009-04-15 | 7 | 3 |
| K042553 | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER | Biocardia, Inc. | 2005-02-17 | 150 | 0 |
| K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | Biocardia, Inc. | 2002-01-24 | 161 | 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