510(k) · Cleared
Recalled · Class II · 2015Fresenius 2008K @Home with Wireless Wetness Detector
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 Feb 3, 2011 as substantially equivalent to K994267 (Fresenius Medical Care, 2000) after a 1,491-day review. Its family tree reaches back 2 generations to 1994. 3 of the 16 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 3, 2011
- Review
- 1,491 days
- Class
- Class II
- Product code
- ONW
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921456 (1994). 13 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 · 2 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 1 generation backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- This deviceK070049 Fresenius 2008K @Home with Wireless Wetness DetectorFresenius Medical Care North America · 2011
- Descendant · cites it directly · 12 of its ownK121421 Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness…Fresenius Medical Care North America, Design Cente · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- Descendant · 3 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 · 4 generations on · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 5 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K121421Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)Fresenius Medical Care North America, Design Cente · 2013 · cites it directly12descendants
- K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013 · 2 generations on11descendants
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 3 generations on9descendants
- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · 4 generations on8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −1 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| 0 (this device) | K070049 | Fresenius 2008K @Home with Wireless Wetness Detector | Fresenius Medical Care North America | 2011 | — |
| +1 | K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector… | Fresenius Medical Care North America, Design Cente | 2013 | 2 |
| +2 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| +3 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| +4 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| +5 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K994267 | Fresenius 2008KSummary page 2…r is a modified version of the Fresenius 2008K, which was cleared under the following premarket notification: Fresenius 2008K Dialysate Delivery System aK994267 (3/10/2000) D. Device Description: The Eresenius 2008K@home machine is a modified version of the 2008K 3- stream hemodia… | 2000 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) | 2013 | 12 |
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. |
| Nov 12, 2013 | Class II | Z-0629-2014 | Under Investigation by firm | 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup |
| Aug 29, 2013 | Class II | Z-0186-2014 | Labeling design | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| Aug 29, 2013 | Class II | Z-0184-2014 | Labeling design | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| Aug 29, 2013 | Class II | Z-0185-2014 | Labeling design | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| Aug 11, 2011 | Not classified | Z-3269-2011 | Device Design | Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions |
| May 4, 2011 | Not classified | Z-3083-2011 | Device Design | Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k) |
The 5 latest of 7 recalls; the web page lists all.
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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K121421 (Fresenius Medical Care North America, Design Cente, 2013) has gone furthest, with 12 descendants of its own.
- 7 other devices also cite its predicate K994267.
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. 2011, 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/K070049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070049: Fresenius 2008K @Home with Wireless Wetness Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070049
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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