ACDS— 510(k) K120005
Substantially EquivalentIsopure, Corp.
FDA 510(k) clearance K120005 for ACDS, Substantially Equivalent on 2012-03-29. Applicant: Isopure, Corp.. Device class: 2.
Clearance details
- Applicant
- Isopure, Corp.
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Simpsonville, KY, US
Recent devices under product code KPO
view allMore clearances from Isopure, Corp.
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K120005
K-number listed on FDA's recall record- Z-1739-2022 — 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 distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
- Z-0821-2020 — Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120005.
Data sourced from openFDA. This site is unofficial and independent of the FDA.