ClearanceBrief
510(k) K192017 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

ApplicantFresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US
DecisionSubstantially Equivalent, Apr 24, 2020
ReceivedJul 29, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K192017

DateFirm and productCodeLinked 510(k)
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for
Open, Classified		 KPONone listed
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Open, Classified		 KPONone listed
Jun 1, 2022Fresenius Medical Care Holdings, Inc.
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Terminated		 KPONone listed
May 31, 2022Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Open, Classified		 KPONone listed
May 31, 2022Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Open, Classified		 KPONone listed
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine
Terminated		 KPONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.