# K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Bever Medical Devices Co., Ltd.
- Decided: Feb 13, 2012 after 270 days
- Product code: GBM (Catheter, Urethral)
- 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: 2 generations back to K896729 (1990). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033023: Intermittent Urethral Catheters, Rusch Intl. (2003) Summary page 1.
- K050874: Astra Tech AB Lofric Primo Single Use Urinary Catheter, Astra Tech, Inc. (2005) Summary page 1.

## Most influential descendants
- K161445: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (2016), 0 descendants of its own
- K142767: ThinkMed Intermittent Catheter with/without Hydrophilic Coating (2015), 0 descendants of its own

## Indications for use
The BEVERm intermittent 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/K111405
Methodology: https://510kreport.com/methodology