510(k) · Cleared
ClearedFresenius Icare Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · FKP System, Dialysate Delivery, Single Patient
Cleared on Nov 13, 2002 after a 225-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 13, 2002
- Review
- 225 days
- Class
- Class II
- Product code
- FKP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK021060 Fresenius Icare Monitoring SystemFresenius Medical Care North America · 2002
- Descendant · cites it directly · 2 of its ownK040074 Oneview InterfaceNxstage Medical, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK133547 Nxstage System One with NxviewNxstage Medical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK252377 NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K040074Oneview InterfaceNxstage Medical, Inc. · 2004 · cites it directly2descendants
- K133547Nxstage System One with NxviewNxstage Medical, Inc. · 2014 · 2 generations on1descendant
- K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021060 | Fresenius Icare Monitoring System | Fresenius Medical Care North America | 2002 | — |
| +1 | K040074 | Oneview Interface | Nxstage Medical, Inc. | 2004 | — |
| +2 | K133547 | Nxstage System One with Nxview | Nxstage Medical, Inc. | 2014 | 2 |
| +3 | K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Fresenius FDS08 Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040074 | Oneview Interface | 2004 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040074 (Nxstage Medical, Inc., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FKP devicesFKP System, Dialysate Delivery, Single Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKP
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FKP
Too few FKP 510(k)s in any year since 2007 to give a median.
Recalls per year · FKP
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKP
4in 2021
MAUDE reports naming product code FKP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 4 | 26 |
| 2009 | 0 | — | 2 | 22 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fresenius Care Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel.
This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021060: Fresenius Icare Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026