Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
C.R. Bard Inc., Bard Electrophysiology Division · 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) |
|---|---|---|---|---|---|
| K113811 | V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM | C.R. Bard Inc., Bard Electrophysiology Division | 2012-03-16 | 84 | 0 |
| K101331 | LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE | C.R. Bard Inc., Bard Electrophysiology Division | 2010-10-08 | 150 | 0 |
| K082094 | BARD PTFE (TEFLON) COATED GUIDE WIRES | C.R. Bard Inc., Bard Electrophysiology Division | 2008-12-17 | 146 | 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