# K142767: ThinkMed Intermittent Catheter with/without Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Thinkmed Medical Technology Co., Ltd.
- Decided: Feb 3, 2015 after 131 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: 3 generations back to K896729 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,, Hangzhou Bever Medical Devices Co., Ltd. (2012) Summary page 4.

## Indications for use
The ThinkMed Intermittent Catheter with/without Hydrophilic Coating 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/K142767
Methodology: https://510kreport.com/methodology