Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cormed, Inc., Sub. C.R.Bard, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
137 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863606 | BUTTERFLY NON-CORING NEEDLE SET | Cormed, Inc., Sub. C.R.Bard, Inc. | 1986-12-18 | 93 | 1 |
| K860432 | PERCUTANEOUS INTRODUCER KIT | Cormed, Inc., Sub. C.R.Bard, Inc. | 1986-03-31 | 55 | 0 |
| K854019 | PORT-GARD | Cormed, Inc., Sub. C.R.Bard, Inc. | 1985-11-26 | 57 | 0 |
| K850967 | STERILE CORMED MEDIPORT | Cormed, Inc., Sub. C.R.Bard, Inc. | 1985-05-17 | 70 | 0 |
| K850674 | CORMED II AMBULATORY INFUSION PUMP | Cormed, Inc., Sub. C.R.Bard, Inc. | 1985-04-09 | 48 | 0 |
| K843083 | CORMED HUBER POINT NEEDLE | Cormed, Inc., Sub. C.R.Bard, Inc. | 1984-09-05 | 30 | 0 |
| K833915 | VASCULAR ACCESS CATH. REPAIR KIT | Cormed, Inc., Sub. C.R.Bard, Inc. | 1984-03-30 | 137 | 0 |
| K823553 | CORCATH H & B VASCULAR ACCESS CATHETER | Cormed, Inc., Sub. C.R.Bard, Inc. | 1983-01-05 | 35 | 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