Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System— 510(k) K201867
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K201867 for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System, Substantially Equivalent on 2020-11-19. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FKX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
Recent devices under product code FKX
view all- K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1) +4 more
- K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
- K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
- K222318 — Fresenius Liberty Select Cycler
- K212522 — Lilliput APD System
More clearances from Baxter Healthcare Corporation
view all- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
Adverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201867
K-number listed on FDA's recall record- Z-0409-2026 — Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
- Z-1316-2023 — Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201867.
Data sourced from openFDA. This site is unofficial and independent of the FDA.