510(k) K120005 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
ACDS
| Applicant | Isopure, Corp., Simpsonville KY, US |
| Decision | Substantially Equivalent, Mar 29, 2012 |
| Received | Jan 3, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2022 | Isopure Corp Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in
Hemodialysis facilities for the storage and Terminated |
KPO | None listed |
| Jan 19, 2020 | Isopure Corp Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3 Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.