Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bard Electrophysiology · 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) |
|---|---|---|---|---|---|
| K042105 | CLIPPER DIAGNOSTIC ELECTRODE CATHETER | Bard Electrophysiology | 2004-09-23 | 50 | 0 |
| K913875 | BARD(R) BIOPOTENTIAL AMPLIFIER II | Bard Electrophysiology | 1991-11-27 | 90 | 0 |
| K893611 | BARD PLAQUE ELECTRODE ARRAY | Bard Electrophysiology | 1989-07-14 | 65 | 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