510(k) · Cleared
ClearedOneview Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · FKP System, Dialysate Delivery, Single Patient
Cleared on Apr 8, 2004 as substantially equivalent to K921456 (Fresenius USA, Inc., 1994) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Apr 8, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- FKP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921456 (1994). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- This deviceK040074 Oneview InterfaceNxstage Medical, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK133547 Nxstage System One with NxviewNxstage Medical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK252377 NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| 0 (this device) | K040074 | Oneview Interface | Nxstage Medical, Inc. | 2004 | — |
| +1 | K133547 | Nxstage System One with Nxview | Nxstage Medical, Inc. | 2014 | 2 |
| +2 | K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery SystemSummary page 1…ntial Equivalence/Predicate Devices: The proposed NxStage OneView Interface is substantially equivalent to the Fresenius Documentation System (FDS-08), K921456, cleared on 04/20/94 and the Fresenius iCare Monitoring System, K021 060 cleared on 11/13/02. D. Device Descriptio… | 1994 |
| * | K021060 | Fresenius Icare Monitoring SystemSummary page 1…ace is substantially equivalent to the Fresenius Documentation System (FDS-08), K921456, cleared on 04/20/94 and the Fresenius iCare Monitoring System, K021 060 cleared on 11/13/02. D. Device Description/indications for Use: OneView is an optional computer-based interface acc… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133547 | Nxstage System One with Nxview | 2014 | 1 |
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?
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?
OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access.
OneView is contraindicated as the sole method of monitoring a patient during treatment,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040074: Oneview Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040074
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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