Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pathway, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% | Pathway, LLC | 2020-04-21 | 266 | 0 |
| K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018-09-21 | 94 | 0 |
| K162233 | Kurin Blood Culture Collection Set | Pathway, LLC | 2016-12-23 | 137 | 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