# K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French

- Pathway: 510(k) (Traditional)
- Applicant: Hakki Medical Technologies, Inc.
- Decided: Feb 7, 2011 after 215 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 K910197 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070879: Bard Malecot and Pezzer Drains, C.R. Bard, Inc. (2007) Summary page 1.
- K040658: Bardex I.C. Latex Foley Catheter, C.R. Bard, Inc. (2004) Summary page 1.

## Most influential descendants
- K191512: LotusCatheter (Lotus No Balloon Catheter) (2020), 0 descendants of its own

## Indications for use
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. it must be connected to a standard urinary collector.

Source page: https://510kreport.com/device/K101900
Methodology: https://510kreport.com/methodology