# K934069: Millex, Dualex (Plus, Ultra)

- Pathway: 510(k) (Traditional)
- Applicant: Millipore Corp.
- Decided: Apr 21, 1994 after 244 days
- Product code: FIB (Protector, Transducer, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), 12 descendants of its own
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K043436: Nxstage Dialysate Preparation Module, Model NX0269 (2005), 5 descendants of its own
- K060296: Nxstage Dialysate Preparation Module (2006), 3 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own

Source page: https://510kreport.com/device/K934069
Methodology: https://510kreport.com/methodology