# K791899: Cycler Sets Mod. #5C4143, 5C4144, 5C4145

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Nov 13, 1979 after 49 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 2 (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
- K214016: 15L Cycler Drainage Bag (2022), 0 descendants of its own

## Recalls of this device
- Oct 6, 2015 · Class II · Z-0194-2016: Leakage from the inlet port of the 15L Cycler Drainage Bags.
- Oct 17, 2013 · Class II · Z-0080-2015: The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

Source page: https://510kreport.com/device/K791899
Methodology: https://510kreport.com/methodology