# K973364: 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage Bag

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical A/S
- Decided: Mar 17, 1998 after 190 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 K843480 (1984). 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)
- K843480: Pharma-Plast Urinary Drainage Bag 2000, Zimmar Consulting, Ltd. (1984) Summary page 1.

## Indications for use
The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same.

Source page: https://510kreport.com/device/K973364
Methodology: https://510kreport.com/methodology