# K124018: Amia Automated PD System

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research & Development Corp.
- Decided: Jun 14, 2013 after 169 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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: 4 generations back to K923065 (1994). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103220: Voyager Peritoneal Dialysis System, Deka Research & Development Corp. (2011) Summary page 1.

## Most influential descendants
- K151525: Amia Automated PD System with Sharesource (2015), 1 descendant of its own
- K201867: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (2020), 0 descendants of its own

## Recalls of this device
- Apr 24, 2014 · Class II · Z-0932-2015: System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

## Indications for use
The Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.

Source page: https://510kreport.com/device/K124018
Methodology: https://510kreport.com/methodology