# K882498: Extended Life Capd Transfer Set 5C4444

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 13, 1988 after 26 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
2 of 4 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
- K152675: Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter (2015), 2 descendants of its own
- K231849: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (2024), 0 descendants of its own
- K192705: MiniCap Extended Life PD Transfer Sets (2019), 0 descendants of its own

## Recalls of this device
- Apr 28, 2014 · Class II · Z-2246-2017: Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
- Feb 25, 2013 · Class II · Z-2474-2015: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution again
- Feb 25, 2013 · Class II · Z-2472-2015: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution again
- Feb 25, 2013 · Class II · Z-2473-2015: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution again
- Feb 25, 2013 · Class II · Z-2471-2015: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution again
- Jul 2, 2009 · Not classified · Z-1893-2009: The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.
- Jul 2, 2009 · Not classified · Z-1894-2009: The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.

Source page: https://510kreport.com/device/K882498
Methodology: https://510kreport.com/methodology