510(k) · Cleared
ClearedDIASAFEplusUS (F00013010)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · FIP Subsystem, Water Purification
Cleared on Oct 9, 2025 as substantially equivalent to K243505 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) after a 115-day review. Its family tree reaches back 14 generations to 1994. 4 of the 60 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 9, 2025
- Review
- 115 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K921456 (1994). 59 ancestors in all, the oldest K770691 (1977). No later device cites it as a predicate yet. 4 of the 60 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 10 generations between
- 3 generations backK222952 2008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · Recalled (Class I)
- 2 generations backK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- 1 generation backK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- This deviceK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
Show all 14 generations
- Root · 14 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 13 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 12 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 11 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 10 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- 9 generations backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 8 generations backK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 7 generations backK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- 6 generations backK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- 5 generations backK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- 4 generations backK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- 3 generations backK222952 2008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · Recalled (Class I)
- 2 generations backK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- 1 generation backK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- This deviceK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −13 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −12 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −11 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −10 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| −9 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| −8 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| −7 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| −6 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| −5 | 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 |
| −3 | K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | Class I |
| −2 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| −1 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| 0 (this device) | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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.
4 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 FIP device
- #1 K250471 AquaC UNO Hscore 11.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K243505 | 5008X Hemodialysis SystemSummary page 5…: Gastroenterology/Urology 1.3. Legally Marketed Predicate Device The legally marketed primary predicate device is the DIASAFE®plusUS filter cleared under K243505. The predicate has not been subject to a design-related recall. 1.4. Device Description 1.4.1. Device Identification… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 3 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
- K080807Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 17 Class I recalls
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 5 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 24 of the 59 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, 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 | 1 | — | 0 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system).…
Read the full statement (107 words)
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system). The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.
The DIASAFE®plusUS can only be used with Fresenius Medical Care hemodialysis machines fitted for use with the DIASAFE®plusUS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251851: DIASAFEplusUS (F00013010).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251851
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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