510(k) · Cleared
Cleared2008K@Home Hemodialysis Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · ONW Hemodialysis System For Home Use
Cleared on Jul 3, 2013 as substantially equivalent to K121421 (Fresenius Medical Care North America, Design Cente, 2013) and 1 other predicate after a 187-day review. Its family tree reaches back 7 generations to 1994. 3 of the 24 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Jul 3, 2013
- Review
- 187 days
- Class
- Class II
- Product code
- ONW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921456 (1994). 12 ancestors in all, the oldest K873155 (1987). 11 later devices descend from it, 2 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 6 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 5 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 4 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 3 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- 2 generations backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 1 generation backK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- This deviceK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- Descendant · cites it directly · 9 of its ownK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 3 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- Descendant · 4 generations on · 4 of its ownK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- Descendant · 4 generations on · 3 of its ownK222952 2008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · cites it directly9descendants
- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · 2 generations on8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 3 generations on7descendants
- K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · 4 generations on4descendants
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −6 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −5 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −4 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −3 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| −2 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| −1 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| 0 (this device) | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| +1 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| +2 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| +3 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| +4 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 |
| +4 | K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 1 | 1 |
| 2022 | 1 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ONW device
- #1 K242269 SC+ Hemodialysis Device (SC-14269); Dialysate…score 11.0 · 10 generations · no Class I recall
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 |
|---|---|---|---|
| * | K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) Cleared while this submission was under review Summary page 3…ics The technological characteristics of the proposed device are summarized in context with the named predicate devices: 2008K@home Hemodialysis Machine with Wet Alert (K121421 - under review) The modified device has the same operating principle, fundamental scientific technology, and iscomparable in key… | 2013 |
| * | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemSummary page 1…Legally Marketed Predicate Devices Fresenius 2008K@home Hemodialysis Machine (K(121421 - under review) and Fresenius 2008T Hemodialysis Machine with bilbag System (K121341). Volume 1… | 2012 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 9 of the 12 ancestors have a recall of any class.
- Of its descendants, K150708 (Fresenius Medical Care Renal Therapies Group, LLC, 2015) has gone furthest, with 9 descendants of its own.
How does its category compare?
All ONW devicesONW Hemodialysis System For Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ONW
Too few ONW 510(k)s in any year since 2007 to give a median.
Recalls per year · ONW
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONW
1in 2025
MAUDE reports naming product code ONW, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 2 | — | 3 | 8 |
| 2014 | 0 | — | 0 | 35 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
2008K@home Hemodialysis Machine: The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System: The Fresenius Medical Care bibag System is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag…
Read the full statement (158 words)
2008K@home Hemodialysis Machine:
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
bibag System:
The Fresenius Medical Care bibag System is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Wireless Wetness Detector (Wet Alert):
The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124035: 2008K@Home Hemodialysis Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124035
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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