# K780032: Urinary Leg Bag

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 17, 1978 after 8 days
- Product code: FAQ (Bag, Urine Collection, Leg, For External Use, Sterile)
- Device class: 1
- Regulation: 21 CFR 876.5250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972887: Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag (1997), 0 descendants of its own

## Recalls of this device
- Mar 25, 2003 · Not classified · Z-0732-03: There is a potential for package seals to be open after sterilization.

Source page: https://510kreport.com/device/K780032
Methodology: https://510kreport.com/methodology