# K022412: Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Mar 5, 2003 after 224 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 5 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CAPD Safe-LockTMTransfer Sets with Pre-filled Connector: named in the summary without a submission number

## Most influential descendants
- K041792: Fresenius Staysafe Patient Connectors, Model 050-87211 (2004), 1 descendant of its own
- K173651: Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (2018), 0 descendants of its own

## Recalls of this device
- Jan 23, 2024 · Class I · Z-1323-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1324-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1326-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1327-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1325-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

## Indications for use
The Fresenius CAPD stayesafe@Disposable Administration Sets with stayesafe@Connector is indicated for use in end stage acute and chronic renal disease.

Source page: https://510kreport.com/device/K022412
Methodology: https://510kreport.com/methodology