Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C. R. Bard — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
367 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Te | C. R. Bard | 2020-03-05 | 367 | 0 |
| K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking Syste | C. R. Bard | 2018-10-24 | 62 | 0 |
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017-09-22 | 25 | 0 |
| K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5 | C. R. Bard | 2017-05-01 | 90 | 0 |
| K162193 | XenMatrix AB Surgical Graft | C. R. Bard | 2016-12-23 | 141 | 0 |
| K151177 | XenMatrix AB Surgical Graft | C. R. Bard | 2015-07-30 | 90 | 0 |
| K142818 | Phasix Mesh | C. R. Bard | 2015-03-31 | 183 | 0 |
| K140501 | XENMATRIX SURGICAL GRAFT | C. R. Bard | 2014-04-28 | 60 | 0 |
| K112791 | SITESCRUB IPA DEVICE | C. R. Bard | 2012-02-24 | 151 | 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