# K140945: Compactcath Intermittent Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Compactcath, Inc.
- Decided: Aug 22, 2014 after 130 days
- Product code: EZD (Catheter, Straight)
- 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 K003784 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K100878: Self Cath Catheter, Coloplast Manufacturing Us, LLC (2010) Summary page 5.

## Most influential descendants
- K160858: CompactCath Intermittent Urinary Catheter (2016), 1 descendant of its own
- K180738: COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (2018), 0 descendants of its own

## Indications for use
CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non- neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Source page: https://510kreport.com/device/K140945
Methodology: https://510kreport.com/methodology