510(k) · Cleared
Recalled · Class II · 2023Amia Automated PD System with Sharesource
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research and Development · FKX System, Peritoneal, Automatic Delivery
Cleared on Oct 9, 2015 as substantially equivalent to K124018 (Deka Research & Development Corp., 2013) and 1 other predicate after a 123-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Oct 9, 2015
- Review
- 123 days
- Class
- Class II
- Product code
- FKX
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 5 generations to K923065 (1994). 10 ancestors in all, the oldest K902149 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK923065 Baxter Personal Cycler Autommated Peritoneal DialBaxter Healthcare Corp · 1994 · Recalled
- 4 generations backK012988 Homechoice Personal Cycler Peritoneal Dialysis System, Models…Baxter Healthcare Corp · 2001 · Recalled
- 3 generations backK043363 Fresenius Liberty CyclerFresenius Medical Care North America · 2005 · Recalled
- 2 generations backK103220 Voyager Peritoneal Dialysis SystemDeka Research & Development Corp. · 2011
- 1 generation backK124018 Amia Automated PD SystemDeka Research & Development Corp. · 2013 · Recalled
- This deviceK151525 Amia Automated PD System with SharesourceDeka Research and Development · 2015
- Descendant · cites it directly · 0 of its ownK201867 Homechoice Claria APD System, Sharesource Connectivity Platform for…Baxter Healthcare Corporation · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…Baxter Healthcare Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923065 | Baxter Personal Cycler Autommated Peritoneal Dial | Baxter Healthcare Corp | 1994 | 4 |
| −4 | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302… | Baxter Healthcare Corp | 2001 | 9 |
| −3 | K043363 | Fresenius Liberty Cycler | Fresenius Medical Care North America | 2005 | 9 |
| −2 | K103220 | Voyager Peritoneal Dialysis System | Deka Research & Development Corp. | 2011 | — |
| −1 | K124018 | Amia Automated PD System | Deka Research & Development Corp. | 2013 | 1 |
| 0 (this device) | K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015 | — |
| +1 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with… | Baxter Healthcare Corporation | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FKX device
- #1 K243371 Byonyks X-1 APD Cycler; Byonyks Automated PD…score 11.1 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K124018 | Amia Automated PD SystemSummary page 4…ogy/Urology Predicate Device(s) The Amia Automated PD System is substantially equivalent to the Amia Automated PD System, which was previously cleared under application K124018. The HomeChoice PRO Automated Personal Cycler previously cleared under K102936 is also included as a reference predicate. The Sha… | 2013 |
| * | K061515 | RenalsoftSummary page 4…ded as a reference predicate. The Sharesource software is substantially equivalent to Baxter Healthcare Corporation’s RenalSoft v.2.0, which was previously cleared under K061515. The PDK accessory for the Amia Automated PD System (K124018) is also included as a reference predicate. Device Description The… | 2006 |
| † | K102936 | Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2023 | Class II | Z-0550-2024 | Process control | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. |
| Jun 30, 2021 | Class II | Z-2173-2021 | Under Investigation by firm | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria… |
| Jun 30, 2021 | Class II | Z-2174-2021 | Under Investigation by firm | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria… |
| Dec 11, 2018 | Class II | Z-0849-2019 | Software design | Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy |
| Dec 11, 2018 | Class II | Z-0850-2019 | Software design | Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy |
| Jul 12, 2018 | Class II | Z-2597-2018 | Under Investigation by firm | There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket. |
| Sep 1, 2017 | Class II | Z-3133-2017 | Equipment maintenance | The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette. |
| Feb 16, 2016 | Class II | Z-1565-2016 | Under Investigation by firm | Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume.… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 8 of the 10 ancestors have a recall of any class.
- Of its descendants, K201867 (Baxter Healthcare Corporation, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FKX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FKX
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FKX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKX
3,128in 2025
MAUDE reports naming product code FKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 147 |
| 2008 | 0 | — | 0 | 702 |
| 2009 | 0 | — | 0 | 340 |
| 2010 | 0 | — | 5 | 4,966 |
| 2011 | 2 | — | 2 | 11,304 |
| 2012 | 0 | — | 2 | 18,034 |
| 2013 | 2 | — | 1 | 22,093 |
| 2014 | 1 | — | 4 | 28,289 |
| 2015 | 1 | — | 2 | 24,663 |
| 2016 | 0 | — | 1 | 6,137 |
| 2017 | 1 | — | 0 | 3,127 |
| 2018 | 2 | — | 3 | 5,927 |
| 2019 | 0 | — | 0 | 5,972 |
| 2020 | 1 | — | 1 | 4,598 |
| 2021 | 0 | — | 0 | 5,076 |
| 2022 | 4 | 209 | 0 | 4,503 |
| 2023 | 0 | — | 2 | 3,913 |
| 2024 | 0 | — | 0 | 3,771 |
| 2025 | 2 | — | 1 | 3,128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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. The Sharesource portal is intended for use by healthcare professionals to remotely communicate new…
Read the full statement (120 words)
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.
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients’ historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151525: Amia Automated PD System with Sharesource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151525
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026