# K972887: Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 11, 1997 after 128 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 K780032 (1978). 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)
- K780032: Urinary Leg Bag, C.R. Bard, Inc. (1978) Summary page 1.
- (no number) Medline’s Urine Collector Leg Bag: named in the summary without a submission number

## Indications for use
These devices are indicated for use by incontinent persons or persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.

Source page: https://510kreport.com/device/K972887
Methodology: https://510kreport.com/methodology