510(k) · Cleared
ClearedNxstage Dosing Calculator
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 Jul 11, 2013 as substantially equivalent to K955423 (Fresenius USA, Inc., 1996) after a 139-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 11, 2013
- Review
- 139 days
- Class
- Class II
- Product code
- FKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955423 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955423 Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFresenius USA, Inc. · 1996
- This deviceK130460 Nxstage Dosing CalculatorNxstage Medical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software Program | Fresenius USA, Inc. | 1996 | — |
| 0 (this device) | K130460 | Nxstage Dosing Calculator | Nxstage Medical, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramSummary page 2…antial Equivalence: The NxStage System Dosing Calculator is substantially equivalent to the Fresenius Pack H Hemodialysis Urea Kinetic Modeling Software Program, K<955423. E. Device Description/indications for Use: Device Description: The NxStage Dosing Calculator is a software modeling progr… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2013, this device’s year, is highlighted.
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 NxStage Dosing Calculator is intended to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130460: Nxstage Dosing Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130460
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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