# K110518: IBAG

- Pathway: 510(k) (Traditional)
- Applicant: Future Path Medical, LLC
- Decided: Jun 24, 2011 after 121 days
- Product code: KNX (Collector, Urine, (And Accessories) For Indwelling Catheter)
- Device class: 2
- Regulation: 21 CFR 876.5250
- 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 K924436 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924436: Bard Urotrack II Monitoring, C.R. Bard, Inc. (1994) Summary page 1.

## Indications for use
This device is intended to measure/display collected urine volume. It detects fill level and temperature.

Source page: https://510kreport.com/device/K110518
Methodology: https://510kreport.com/methodology