# K001283: Lifemate Hemofiltration System

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Jan 17, 2001 after 271 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.
34 later devices descend from it; 1 cites it directly.
0 of 35 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
- K012510: Modification to: Lifemate Hemofiltration System (2001), 33 descendants of its own
- K020858: Nxstage Therapy System (2002), 32 descendants of its own
- K030470: Nxstage System One (2003), 29 descendants of its own
- K041424: Nxstage System One (2004), 28 descendants of its own
- K050525: Nxstage System One (2005), 27 descendants of its own

Source page: https://510kreport.com/device/K001283
Methodology: https://510kreport.com/methodology