510(k) · Cleared
ClearedDIASAFEplusUS
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 Jan 10, 2019 as substantially equivalent to K944767 (Fresenius USA, Inc., 1995) after a 132-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Jan 10, 2019
- Review
- 132 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944767 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944767 Dialysis Machine with Dialysate UltrafilterFresenius USA, Inc. · 1995
- This deviceK182367 DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC · 2019
- Descendant · cites it directly · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
Most influential descendants
Showing 3 of 3 · See all- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · cites it directly2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on1descendant
- K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944767 | Dialysis Machine with Dialysate Ultrafilter | Fresenius USA, Inc. | 1995 | — |
| 0 (this device) | K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | 2019 | — |
| +1 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| +2 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +3 | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in FIP? 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 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 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 |
|---|---|---|---|
| * | K944767 | Dialysis Machine with Dialysate UltrafilterSummary page 4…el: Gastroenterology/Urology 5.3. Legally Marketed Predicate Device The legally marketed predicate device is the Dialysis Machine with Dialysate Ultrafilter (K944767), hereinafter referred to as “Diasafe Dialysate Ultrafilter”. This predicate has not been subject to a design-related recall. 5.… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231534 | 5008X Hemodialysis System | 2024 | 2 |
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.
- Of its descendants, K231534 (Fresenius Medical Care, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 dialysate from pre-treated 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 dialysis machines fitted for use with DIASAFE®plusUS.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182367: DIASAFEplusUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182367
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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