# K151745: FULL CARE Disposable PVC Nelaton Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Shaoxing Fuqing Health Products Co., Ltd.
- Decided: Mar 3, 2016 after 248 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: 5 generations back to K896729 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072539: Cure Catheter, Cure Medical, LLC (2007) Summary page 6.
- K110653: Cure Catheter, Cure Medical, LLC (2011) Summary page 6.
- K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated, Cure Medical, LLC (2013) Summary page 6.
- K080881: Cure Catheter Closed System, Cure Medical, LLC (2008) Summary page 6.

## Indications for use
The FULL CARE Disposable PVC Nelaton Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Source page: https://510kreport.com/device/K151745
Methodology: https://510kreport.com/methodology