Atlas FDA

FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES

FDA 510(k) clearance K070177 · decided 2007-03-29

Clearance details

K-number
K070177
Device name
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
Applicant
Fresenius Medical Care North America
Decision
Substantially Equivalent
Date received
2007-01-18
Decision date
2007-03-29
Days to decision
70 days
Clearance type
Special
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per recall (Z-0181-2023)Fresenius Medical Care Holdings, Inc.2022-11-04
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used i recall (Z-0811-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used i recall (Z-0812-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used i recall (Z-0813-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used i recall (Z-0814-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used i recall (Z-0815-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used i recall (Z-0816-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used i recall (Z-0817-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used i recall (Z-0818-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used i recall (Z-0819-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used i recall (Z-0820-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used i recall (Z-0821-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used i recall (Z-0822-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in recall (Z-0823-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in recall (Z-0824-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in recall (Z-0825-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in recall (Z-0826-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used i recall (Z-0827-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in recall (Z-0828-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in recall (Z-0829-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used i recall (Z-0831-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used i recall (Z-0832-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used i recall (Z-0833-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used i recall (Z-0834-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used i recall (Z-0835-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used i recall (Z-0836-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used i recall (Z-0837-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used i recall (Z-0838-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in recall (Z-0839-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in recall (Z-0840-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in recall (Z-0841-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid recall (Z-0887-2016)Fresenius Medical Care Renal Therapies Group, LLC2016-02-25