Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMZ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
101 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153069 | Edwards Balloon Catheter | Edwards Lifesciences | 2016-01-07 | 77 | 0 |
| K131002 | VIDA PTV DILATATON CATHETER | C.R. Bard, Inc. | 2013-07-02 | 83 | 0 |
| K122367 | BARD PTV DILATATION CATHETER | C.R. Bard, Inc. | 2012-11-02 | 88 | 0 |
| K102473 | MULLINS-X PTV CATHETER | NuMED, Inc. | 2010-12-09 | 101 | 0 |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | NuMED, Inc. | 2002-01-16 | 30 | 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