PRISMAFLEX— 510(k) K110823
Substantially EquivalentGambro Renal Products, Inc.
FDA 510(k) clearance K110823 for PRISMAFLEX, Substantially Equivalent on 2011-06-17. Applicant: Gambro Renal Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products, Inc.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code KDI
view allMore clearances from Gambro Renal Products, Inc.
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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 K110823
K-number listed on FDA's recall record- Z-1278-2021 — Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
- Z-1828-2020 — Prismaflex System, Prismaflex Control Unit
- Z-1829-2020 — Prismaflex System, Prismaflex Control Unit
- Z-1830-2020 — Prismaflex System, Prismaflex Control Unit
- Z-1831-2020 — Prismaflex System, Prismaflex Control Unit
- Z-1832-2020 — Prismaflex System, Prismaflex Control Unit
- Z-1833-2020 — Prismaflex System, Prismaflex Control Unit
- Z-1923-2018 — Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
- Z-1280-2018 — Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110823.
Data sourced from openFDA. This site is unofficial and independent of the FDA.