# 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

- Pathway: 510(k) (Traditional)
- Applicant: Pathway, LLC
- Decided: Apr 21, 2020 after 266 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984084 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984084: Bardex Lubri-Sil Foley Catheter, Bard Medical Div. (1999) Summary page 4.

## Most influential descendants
- K221625: 2-Way 100% Silicone ClearTract Catheter (2022), 2 descendants of its own
- K222118: 2-Way 100% Silicone Cleartract Catheter (2022), 1 descendant of its own
- K233013: 2-Way 100% Silicone Cleartract Catheter (2024), 0 descendants of its own

## Indications for use
Urological catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.

Source page: https://510kreport.com/device/K192034
Methodology: https://510kreport.com/methodology