Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NVM · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213915 | BIB Stent Placement Catheter | NuMED, Inc. | 2022-01-12 | 28 | 0 |
| K211134 | BIB Stent Placement Catheter | NuMED, Inc. | 2021-05-27 | 41 | 0 |
| K161451 | BIB Stent Placement Catheter | NuMED, Inc. | 2016-09-22 | 119 | 0 |
| K160889 | BIB Stent Placement Catheter | NuMED, Inc. | 2016-05-20 | 50 | 0 |
| K050857 | BIB PTA BALLOON CATHETER | NuMED, Inc. | 2005-07-28 | 114 | 1 |
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