# K152129: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 29, 2015 after 90 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895631 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972579: High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine, Baxter Healthcare Corp (1997) Summary page 6.
- K895631: Disconnect Caps Product Codes 5C4212 and 5C4466, Baxter Healthcare Corp (1990) Summary page 9.

## Recalls of this device
- Feb 1, 2023 · Class II · Z-1213-2023: MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, res

## Indications for use
This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient line connector of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy. This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.

Source page: https://510kreport.com/device/K152129
Methodology: https://510kreport.com/methodology