# K222118: 2-Way 100% Silicone Cleartract Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Silq Technologies, Corp.
- Decided: Dec 1, 2022 after 136 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: 3 generations back to K984084 (1999). 3 ancestors in all.
1 later device descends 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)
- K221625: 2-Way 100% Silicone ClearTract Catheter, Silq Technologies Corporation (2022) Summary page 4.

## Most influential descendants
- 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 generally accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic placement or other placement of the catheter, such as nephrostomy tract. Intended population is adults and pediatrics.

Source page: https://510kreport.com/device/K222118
Methodology: https://510kreport.com/methodology