# Pathway, LLC

- Location (FDA's records): Santee, CA
- FDA decisions: 3 (2016–2020): 3 510(k) clearances
- Product codes: EZL (2), JKA (1)
- 510(k) review time since 2016: median 137 days, against 137 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bard Medical Div.: 1 (https://510kreport.com/company/bard-medical-div)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Ryan Medical, Inc.: 1 (https://510kreport.com/company/ryan-medical)

## Firms that cite its devices most
- Kurin, Inc.: 2 (https://510kreport.com/company/kurin)
- Silq Technologies Corporation: 1 (https://510kreport.com/company/silq-technologies)

## Its most-cited devices
- K162233: Kurin Blood Culture Collection Set (2016), cited by 2
- K192034: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc (2020), cited by 1

## Recent decisions
- K192034: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc (Apr 21, 2020)
- K181616: PSM 3-Way Silicone Foley Catheter (Sep 21, 2018)
- K162233: Kurin Blood Culture Collection Set (Dec 23, 2016)

Source page: https://510kreport.com/company/pathway