Subsystem, Proportioning

Device Code: 1909

Product Code(s): FKR

Device Classification Information

• Device Type ID: 1909
• Device Name: Subsystem, Proportioning
• Regulation Description: Hemodialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5820 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FKR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-98 ISO 13959 Third Edition 2014-04-01
  Water For Haemodialysis And Related Therapies
• 9-99 ISO 23500 Second Edition 2014-04-01
  Guidance For The Preparation And Quality Management Of Fluids For Haemodialysis And Related Therapies
• 9-100 ISO 11663 Second Edition 2014-04-01
  Quality Of Dialysis Fluid For Haemodialysis And Related Therapies

Total Product Life Cycle

• Device Type ID: 1909
• Device: Subsystem, Proportioning
• Product Code: FKR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hemodialysis System And Accessories.
• CFR Regulation Number: 876.5820 [🔎]

Premarket Reviews
Manufacturer	Decision
NXSTAGE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NXSTAGE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	NxStage Medical, Inc.	II	Mar-01-2018
2	NxStage Medical, Inc.	II	Jun-24-2014

TPLC Last Update: 2019-04-02 20:01:46