# K173363: Cycler Drain Bag Set

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Jan 24, 2018 after 90 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895991 (1990). 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)
- K895991: Peritoneal Dialysis Drainage Set NO. 48-0025-6, National Medical Care, Medical Products Div., Inc. (1990) Summary page 4.

## Recalls of this device
- Apr 28, 2021 · Class II · Z-2083-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions

## Indications for use
The Cycler Drain Bag Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.

Source page: https://510kreport.com/device/K173363
Methodology: https://510kreport.com/methodology