# K895631: Disconnect Caps Product Codes 5C4212 and 5C4466

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jan 29, 1990 after 132 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 4 (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; 3 cite it directly.
0 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
- K972579: High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine (1997), 2 descendants of its own
- K152129: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (2015), 0 descendants of its own
- K031676: Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q (2003), 0 descendants of its own

## Recalls of this device
- Jan 22, 2015 · Class II · Z-1269-2015: Product may have separating or protruding sponges
- Jun 17, 2014 · Class II · Z-2074-2014: Inadequate iodine and packaging related defects.
- Jul 8, 2013 · Class II · Z-1945-2014: the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
- May 21, 2013 · Class II · Z-1565-2013: leaking pouches

Source page: https://510kreport.com/device/K895631
Methodology: https://510kreport.com/methodology