# K214016: 15L Cycler Drainage Bag

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 18, 2022 after 86 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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 K791899 (1979). 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)
- K791899: Cycler Sets Mod. #5C4143, 5C4144, 5C4145, Travenol Laboratories, S.A. (1979) Summary page 6.

## Indications for use
This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy.

Source page: https://510kreport.com/device/K214016
Methodology: https://510kreport.com/methodology