Home › Device types › FKX
System, Peritoneal, Automatic Delivery
FDA product code FKX · Class 2 · Gastroenterology, Urology
67
Registered devices
164,498
Adverse events
51
Recalls
83
510(k) clearances
Devices with this code
Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC.Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC.AUTOMATED PD SET — BAXTER INTERNATIONAL INC.VersiPD — Fresenius Usa, Inc.Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC.Extension Set — BAXTER INTERNATIONAL INC.AMIA Automated PD Cycler — BAXTER INTERNATIONAL INC.LOW RECIRCULATION VOLUME APD SET — BAXTER INTERNATIONAL INC.Safe-Lock® — Fresenius Medical Care Holdings, Inc.Liberty — Fresenius Medical Care Renal Therapies Group, LLCSharesource Connectivity Platform — BAXTER INTERNATIONAL INC.VersiPD — Fresenius Medical Care Holdings, Inc.CloudCath Sensor (Sensing Hardware) — Gastroklenz Inc.Peritoneal Dialysis — Merit Medical Systems, Inc.LOW RECIRCULATION VOLUME APD SET — BAXTER INTERNATIONAL INC.INTERGRATED APD SET — BAXTER INTERNATIONAL INC.Sharesource — BAXTER HEALTHCARE CORPORATIONLiberty® — Fresenius Medical Care Holdings, Inc.Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC.Premier — Fresenius Medical Care Holdings, Inc.stay•safe® organizer holder — Fresenius Medical Care Holdings, Inc.NA — Baxter Healthcare SAHomeChoice PRO APD System — BAXTER INTERNATIONAL INC.CloudCath Connect - Patient Monitoring Software — Gastroklenz Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-28 | Vantive US Healthcare LLC | Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be pro |
| 2023-11-15 | Baxter Healthcare Corporation | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. |
| 2023-10-24 | Fresenius Medical Care Holdings, Inc. | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. |
| 2023-02-22 | Baxter Healthcare Corporation | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| 2022-04-21 | Baxter Healthcare Corporation | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2021-06-30 | BAXTER HEALTHCARE CORPORATION | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes t |
| 2021-06-30 | BAXTER HEALTHCARE CORPORATION | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes t |
| 2021-04-28 | Fresenius Medical Care Holdings, Inc. | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2020-09-12 | Fresenius Medical Care Holdings, Inc. | The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag t |
| 2019-05-29 | Fresenius Medical Care Renal Therapies Group, LLC | Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) sol |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.