Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bard Access Systems, Inc. (C.R. Bard, Inc.) · 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) |
|---|---|---|---|---|---|
| K233106 | AccuCath Ace™ Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2024-04-19 | 205 | 0 |
| K231283 | SiteRite™ 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 | 131 | 0 |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021-06-25 | 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