AMUKIN-50% for Capd Y-Set

FDA 510(k) K862928 · Amuchina Intl., Inc.

Substantially Equivalent

510(k) numberK862928

Submission

Device name
AMUKIN-50% for Capd Y-Set
Applicant
Amuchina Intl., Inc.
Silver Spring, MD, US
Received
August 1, 1986
Decision date
March 9, 1987
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

Other 510(k)s with product code FKX

510(k)DeviceApplicantDecision
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
K992016Amukin DLIF · Traditional 01/10/2000SE
K952302AmuchinaLRJ · Traditional 07/26/1995SE
K871583Modified Labeling for AMUKIN-50%KDJ · Traditional 07/09/1987SE
K852359Amuchina/Dialyzer DisinfectantFKQ · Traditional 05/13/1986SE

Questions and answers

When was AMUKIN-50% for Capd Y-Set cleared by the FDA?

AMUKIN-50% for Capd Y-Set (K862928) received a 510(k) decision of Substantially Equivalent on March 9, 1987, 220 days after the submission was received.

What is the product code of K862928?

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