# 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

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Bever Medical Devices Co., Ltd.
- Decided: Nov 27, 2019 after 79 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910022 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023254: Speedicath, Coloplast Corp. (2003) Summary page 4.

## Most influential descendants
- K251178: Ready to use Nelaton Catheter (2026), 0 descendants of its own

## Recalls of this device
- Nov 29, 2025 · Class II · Z-1061-2026: Labeling error, Incorrect expiration date

## Indications for use
The Ready-to-use Hydrophilic 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.

Source page: https://510kreport.com/device/K192468
Methodology: https://510kreport.com/methodology