# K083542: Fresenius Sterile Stay Safe Cap

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Dec 29, 2008 after 31 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
Longest line of descent: 1 generation back to K921818 (1994). 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)
- K921818: Abbott Smart Cap, Abbott Laboratories (1994) Summary page 2.

## Recalls of this device
- Oct 10, 2023 · Class II · Z-0507-2024: Updating the labeling to include additional warnings and contraindications for potential side effects.
- Apr 28, 2021 · Class II · Z-2090-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions

## Indications for use
The Fresenius Sterile Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system.

Source page: https://510kreport.com/device/K083542
Methodology: https://510kreport.com/methodology