510(k) clearances

Nipro Dry Acid Concentrate Mixer

Nipro Technical Solutions, Incoporated · Gastroenterology, Urology

K260799Substantially EquivalentTraditionalKPO
Open FDA's page for this record
Third party flag
N
City
Mesa
Advisory committee description
Gastroenterology, Urology
Address 1
3110 N Oakland, Suite 101
Statement or summary
Summary
Product code
KPO
Zip code
85215
Applicant
Nipro Technical Solutions, Incoporated
Decision date
2026-08-19
Decision code
SESE
Country code
US
Device name
Nipro Dry Acid Concentrate Mixer
Advisory committee
GU
Contact
Jessica Oswald-McLeod
K number
K260799
State
AZ
Date received
2026-03-11
Review advisory committee
GU
Postal code
85215
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5820
Device class
2
Registration number
3003591774, 3012364195, 3010242164, 3007137482, 3016096143, 3005162618, 1651896, 3004176176, 3013546115, 3013764800, 3035708507, 2029275, 3043014136, 3005578748, 3019131, 9610725, 3032828299, 1225714, 3027592507, 3038195011, 3003464075, 1954315, 1652176, 1056186, 9610270, 1835498, 1528807, 2183415, 9611823, 9616277, 3027241826, 3003768032, 2431908, 8030639
FEI number
3003591774, 3012364195, 3010242164, 3007137482, 1000306431, 405, 3016096143, 3004176176, 3013546115, 3013764800, 3035708507, 3013942511, 3043014136, 3005578748, 3006475063, 3003463852, 6898, 3012394756, 3032828299, 3027592507, 3038195011, 3003464075, 1000132332, 3003244997, 3001451489, 3002807005, 1527681, 3002970979, 2183415, 3001236991, 3027241826, 1000142899, 3003310249, 2431908
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.