# K212151: FLUME catheter

- Pathway: 510(k) (Traditional)
- Applicant: The Flume Catheter Company, Ltd.
- Decided: Nov 3, 2021 after 117 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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: 1 generation back to K980870 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980870: Rusch Silicone Foley Catheter, Rusch, Inc. (1998) Summary page 4.

## Most influential descendants
- K231101: Flume Catheter (2023), 0 descendants of its own

## Indications for use
The FLUME catheter is intended for the drainage of the urinary tract.

Source page: https://510kreport.com/device/K212151
Methodology: https://510kreport.com/methodology