# K251178: Ready to use Nelaton Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Jamjoom Fullcare Corporation
- Decided: Jan 2, 2026 after 261 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 K910022 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192468: Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter, Hangzhou Bever Medical Devices Co., Ltd. (2019) Summary page 5.

## Indications for use
The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for individuals (men, women, pediatrics) who are unable to promote natural urine flow or have a significant volume of residual urine following a natural bladder-voiding episode. The catheter is inserted into the urethra to reach the bladder, allowing urine to drain and ensuring bladder emptying.

Source page: https://510kreport.com/device/K251178
Methodology: https://510kreport.com/methodology