# K030974: Exeltra High Flux Dialyzer, Models 150 & 170

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 25, 2003 after 28 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
Longest line of descent: 1 generation back to K890315 (1989). 3 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890315: Capillary Flow Dialyzers Models CT110G & CT190G, Baxter Healthcare Corp (1989) Summary page 1.
- K926568: Baxter CT Dialyzer, Baxter Healthcare Corp (1994) Summary page 1.
- K970663: CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G), Baxter Healthcare Corp (1998) Summary page 1.

## Most influential descendants
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), 26 descendants of its own
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210 (2009), 20 descendants of its own
- K082414: Optiflux F250NR, Model 0500325E (2008), 16 descendants of its own
- K123262: Optiflux Ultra Dialyzer (2014), 13 descendants of its own
- K152367: Optiflux dialyzer (2015), 12 descendants of its own

## Indications for use
Hemodialysis with the EXELTRATMDialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs,

Source page: https://510kreport.com/device/K030974
Methodology: https://510kreport.com/methodology