# K182940: Surdial DX Hemodialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Jul 19, 2019 after 269 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K083460 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083460: Dialog with Adimea Option, B. Braun Avitum AG (2010) Summary page 4.

## Recalls of this device
- Oct 27, 2025 · Class II · Z-0912-2026: Screw may loosen or fallout of Hemodialysis system

## Indications for use
The SURDIAL DX Hemodialysis System is indicated for implementing and monitoring hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.

Source page: https://510kreport.com/device/K182940
Methodology: https://510kreport.com/methodology