# K923312: High Permeability Dialyer

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Feb 18, 1994 after 591 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K014152: Nxstage Cartridge Express (2002), 7 descendants of its own
- K032356: Nxstage System One with Cartridge Express (2003), 6 descendants of its own
- K050727: Modification to Nxstage Cartridge Express (2005), 5 descendants of its own
- K061837: Nxstage Cartridge Express (2006), 4 descendants of its own
- K232803: NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K923312
Methodology: https://510kreport.com/methodology