# K191512: LotusCatheter (Lotus No Balloon Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Hakki Medical Technologies, Inc.
- Decided: May 21, 2020 after 349 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 K910197 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French, Hakki Medical Technologies, Inc. (2011) Summary page 4.
- K070879: Bard Malecot and Pezzer Drains, C.R. Bard, Inc. (2007) Summary page 4.

## Indications for use
The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.

Source page: https://510kreport.com/device/K191512
Methodology: https://510kreport.com/methodology