# K013562: Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 with N100 Arm, 4B Software

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Dec 12, 2002 after 412 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910215 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910215: Drake Willock System 1000 Dialysate Delivery Syst, Cd Medical, Inc. (1991)
- K954987: Altratouch 1000 Hemodialysis Delivery System, Althin Medical AB an Affiliate of Baxter Intl (1996)
- K955384: Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option, Althin Medical AB an Affiliate of Baxter Intl (1997) Summary page 1.
- K964922: Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System, Althin Medical AB an Affiliate of Baxter Intl (1997) Summary page 1.
- K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System, Althin Medical AB an Affiliate of Baxter Intl (1997) Summary page 1.
- K992894: Meridian Hemodialysis Machine, Model 5M5576, Baxter Healthcare Corp (1999) Summary page 1.

## Recalls of this device
- Aug 31, 2009 · Not classified · Z-0179-2010: When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manua
- Nov 18, 2005 · Not classified · Z-0347-06: Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air embo

## Indications for use
The AURORATMSystem 1OOO@ Series Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Aurora System 1000 include a high blood flow rate capacity, automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Aurora System 1000 Instrument will operate in either the bicarbonate or acetate mode for concentrates. The AURORATMSystem 1OOO@Series Single Patient Dialysis Delivery System is designed to operate in the chronic and acute dialysis environment. It is not for home use.

Source page: https://510kreport.com/device/K013562
Methodology: https://510kreport.com/methodology