# K180738: COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter

- Pathway: 510(k) (Special)
- Applicant: Compactcath, Inc.
- Decided: Jun 14, 2018 after 84 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: 4 generations back to K003784 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160858: CompactCath Intermittent Urinary Catheter, Compactcath, Inc. (2016) Summary page 4.
- K140945: Compactcath Intermittent Urinary Catheter, Compactcath, Inc. (2014) Summary page 4.

## Indications for use
CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter are indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) 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/K180738
Methodology: https://510kreport.com/methodology