# K971764: Welcon Hue-VU Urinary Drainage Bag

- Pathway: 510(k) (Traditional)
- Applicant: Welcon, Inc.
- Decided: Jul 29, 1997 after 77 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 K780837 (1978). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780837: Urinary Drainage Bag, Intermed, Inc. (1978) Summary page 2.
- K844810: New Bard Infection Control Urinary Drainage Bag, C.R. Bard, Inc. (1985) Summary page 2.
- K940206: Bard Urine Collection Products Modification, C.R. Bard, Inc. (1994) Summary page 2.

## Indications for use
The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.

Source page: https://510kreport.com/device/K971764
Methodology: https://510kreport.com/methodology