# K023664: Syntra + Dialyzer, Model 200

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 21, 2003 after 113 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 K002210 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002210: Syntra Dialyzer, Model Syntra 120, 160, Baxter Healthcare Corp (2001) Summary page 2.

## Indications for use
Hemodialysis with SyntraTM+ is indicated for patients with 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/K023664
Methodology: https://510kreport.com/methodology