Microstar Vci

FDA 510(k) K831766 · Medionics International , Ltd.

Substantially Equivalent

510(k) numberK831766

Submission

Device name
Microstar Vci
Applicant
Medionics International , Ltd.
Mchenry, IL, US
Received
June 1, 1983
Decision date
October 14, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKX – System, Peritoneal, Automatic Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

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K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional Simergent, LLC10/02/2025SE
K243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional Byonyks Pvt, Ltd.05/16/2025SE
K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional Iren-Medical, Ltd.12/29/2022SE
K222318Fresenius Liberty Select CyclerFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC10/31/2022SE
K212522Lilliput APD SystemFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC04/15/2022SE
K212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional Cloudcath02/09/2022SE
K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional Baxter Healthcare Corporation11/19/2020SE
K181108Fresenius Liberty Select CyclerFKX · Special Fresenius Medical Care Renal Therapies Group, LLC05/24/2018SE
K173718Liberty Cycler SetFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC05/01/2018SE
K171652Fresenius Liberty Select CyclerFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC09/15/2017SE

More from Fresenius Medical Care Renal Therapies Group, LLC

510(k)DeviceDecision
K130441Faller StyletFJS · Traditional 04/19/2013SE
K993149Peritoneal Dialysis Catheters and AdaptersFJS · Traditional 04/28/2000SE
K994218Easy Care and Tubing SetsFKX · Special 02/10/2000SE
K945567QC CapKDJ · Traditional 02/07/1995SE
K910173Selectra and Tubing SetsFKX · Traditional 01/13/1992SE
K883393Capd Disposable Y System - Dy SetKDJ · Traditional 11/03/1988SE
K842305C.A.P.D. Automatic Heater PDH 200FKX · Traditional 06/25/1984SE
K832141Microstar VC1 Volumetric CyclerFKX · Traditional 10/14/1983SE
K821328C.A.P.D. Automatic Heater #Pdc 2000 HCPKPF · Traditional 07/28/1982SE

Questions and answers

When was Microstar Vci cleared by the FDA?

Microstar Vci (K831766) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 135 days after the submission was received.

What is the product code of K831766?

The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.