# K212430: BONREE Nelaton Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bonree Medical Co., Ltd.
- Decided: Apr 29, 2022 after 268 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)
- K142575: Bard RiteCath Intermittent Urinary Catheter, C.R. Bard, Inc. (2014) Summary page 4.

## Indications for use
The BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old) for draining urine from the bladder.

Source page: https://510kreport.com/device/K212430
Methodology: https://510kreport.com/methodology