# K972579: High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 1, 1997 after 83 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895631 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895631: Disconnect Caps Product Codes 5C4212 and 5C4466, Baxter Healthcare Corp (1990) Summary page 1.
- K945567: QC CAP, Medionics International, Inc. (1995) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) are single use caps that are intended for use with appropriate Peritoneal Dialysis (PD) products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set. The MiniCap is designed to isolate (cap off) the Easy-Lock™ connector of the patient's transfer set. The High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) is a single use cap that is intended for use with appropriate Peritoneal Dialysis (PD) disposable products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set.

Source page: https://510kreport.com/device/K972579
Methodology: https://510kreport.com/methodology