# K221625: 2-Way 100% Silicone ClearTract Catheter

- Pathway: 510(k) (Special)
- Applicant: Silq Technologies Corporation
- Decided: Jul 1, 2022 after 25 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: 2 generations back to K984084 (1999). 2 ancestors in all.
2 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)
- 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, LLC (2020) Summary page 4.

## Most influential descendants
- 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
The 2-Way 100% Silicone ClearTract 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/K221625
Methodology: https://510kreport.com/methodology