Atlas FDA

ACDS

FDA 510(k) clearance K120005 · decided 2012-03-29

Clearance details

K-number
K120005
Device name
ACDS
Applicant
Isopure, Corp.
Decision
Substantially Equivalent
Date received
2012-01-03
Decision date
2012-03-29
Days to decision
86 days
Clearance type
Special
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Simpsonville, KY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Dis recall (Z-1739-2022)Isopure Corp2022-09-13
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson recall (Z-0821-2020)Isopure Corp2020-01-19