510(k) · Cleared
Recalled · Class II · 2015Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America, Design Cente · ONW Hemodialysis System For Home Use
Cleared on Jan 17, 2013 as substantially equivalent to K070049 (Fresenius Medical Care North America, 2011) after a 248-day review. Its family tree reaches back 3 generations to 1994. 3 of the 16 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 17, 2013
- Review
- 248 days
- Class
- Class II
- Product code
- ONW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921456 (1994). 12 later devices descend from it, 1 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 2 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 1 generation backK070049 Fresenius 2008K @Home with Wireless Wetness DetectorFresenius Medical Care North America · 2011 · Recalled
- This deviceK121421 Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness…Fresenius Medical Care North America, Design Cente · 2013
- Descendant · cites it directly · 11 of its ownK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- Descendant · 2 generations on · 9 of its ownK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 4 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- Descendant · 5 generations on · 4 of its ownK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013 · cites it directly11descendants
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 2 generations on9descendants
- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · 3 generations on8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 4 generations on7descendants
- K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −2 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −1 | K070049 | Fresenius 2008K @Home with Wireless Wetness Detector | Fresenius Medical Care North America | 2011 | 7 |
| 0 (this device) | K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector… | Fresenius Medical Care North America, Design Cente | 2013 | — |
| +1 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| +2 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| +3 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| +4 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| +5 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K070049 | Fresenius 2008K @Home with Wireless Wetness DetectorSummary page 1…1per §876.5860 Legally Marketed Predicate Device (unmodified devices): The Fresenius 2008K@home Hemodialysis Machine with Wireless Wetness Detector (WetAlert) system (K070049) originally 03 February 2011. Device Description: The 2008K@home Hemodialysis Machine with Wireless Wetness Detector is intended… | 2011 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124035 | 2008K@Home Hemodialysis Machine | 2013 | 11 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2015 | Class II | Z-1549-2015 | Software design | The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. |
| Dec 16, 2014 | Class II | Z-1015-2015 | Under Investigation by firm | Unqualified power assemblies shipped to customers. |
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 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 5 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 5.9 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K124035 (Fresenius Medical Care North America, 2013) has gone furthest, with 11 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?
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.
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/K121421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121421: Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121421
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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