Fresenius Icare Monitoring System
FDA 510(k) K021060 · Fresenius Medical Care North America
510(k) numberK021060
Submission
- Device name
- Fresenius Icare Monitoring System
- Applicant
- Fresenius Medical Care North America
Lexington, MA, US - Received
- April 2, 2002
- Decision date
- November 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K964264 | High Range Peroxide Test StripFKP · Traditional | Integrated Biomedical Technology, Inc. | 06/16/1997SE |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | Fresenius USA, Inc. | 06/13/1996SE |
| K953854 | Watercheck Reagent Strip for Chlorine & PeroxideFKP · Traditional | Integrated Biomedical Technology, Inc. | 03/11/1996SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | Fresenius USA, Inc. | 11/29/1995SE |
More from Fresenius USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252181 | AquaAFIP · Traditional | 09/09/2025SE |
| K162488 | Optiflux dialyzerKDI · Traditional | 04/06/2017SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | 11/05/2015SE |
| K152367 | Optiflux dialyzerKDI · Traditional | 10/29/2015SE |
| K123262 | Optiflux Ultra DialyzerKDI · Traditional | 01/06/2014SE |
| K131611 | Fresenius Dry Acid Dissolution UnitsKPO · Traditional | 08/29/2013SE |
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | 07/03/2013SE |
| K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemKDI · Traditional | 12/06/2012SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | 11/09/2012SE |
| K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemKDI · Special | 02/02/2012SE |
Questions and answers
When was Fresenius Icare Monitoring System cleared by the FDA?
Fresenius Icare Monitoring System (K021060) received a 510(k) decision of Substantially Equivalent on November 13, 2002, 225 days after the submission was received.
What is the product code of K021060?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.