Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Silk Road Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
235 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | 2022-09-02 | 109 | 0 |
| K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016-03-10 | 98 | 0 |
| K143459 | Silk Road Acccess Catheter | Silk Road Medical, Inc. | 2015-04-01 | 118 | 0 |
| K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015-02-09 | 105 | 0 |
| K130649 | SILK ROAD ACCESS CATHETER | Silk Road Medical, Inc. | 2013-11-01 | 235 | 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