510(k) · Cleared
Recalled · Class I · 2016Dialog Dialysis Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Medical AG · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jun 26, 1998 as substantially equivalent to K854367 (Organon Teknika Corp., 1985) and 2 other predicates after a 665-day review. Its family tree reaches back 1 generation to 1985. 1 of the 9 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 6 times, including 6 Class I recalls.
- Decided
- Jun 26, 1998
- Review
- 665 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 6 (6 Class I)
- Predicates
- 3
Its longest line of descent runs back 1 generation to K850569 (1985). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK850569 BSM 2000 Dialysis Machine - ModifiedOrganon Teknika Corp. · 1985
- This deviceK963440 Dialog Dialysis MachineB. Braun Medical AG · 1998
- Descendant · cites it directly · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK042938 Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK220281 multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · cites it directly4descendants
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 2 generations on1descendant
- K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · 2 generations on1descendant
- K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations on0descendants
- K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850569 | BSM 2000 Dialysis Machine - Modified | Organon Teknika Corp. | 1985 | — |
| 0 (this device) | K963440 | Dialog Dialysis Machine | B. Braun Medical AG | 1998 | — |
| +1 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| +2 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
| +2 | K042938 | Gambro Prismaflex HF1000 and HF1400 Sets | Gambro Renal Products | 2005 | 7 |
| +3 | K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | — |
| +2 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | 2022 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2022 | 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.
1 device in this family has 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K854367 | HD-Secura Hemadialysis MachineSummary page 1…troenterology & Urology Class Il, 78 FKP, Single Patient Dialysate Delivery System 21 CFR 876.5820 SUBSTANTIAL EQUIVALENCE! TO: 510 (k) Number Applicant Description K854367, K850569 Modified Organon Teknika HD Secura Dialysis Unit K880459 CD Medical 480 High-Flow Ultrafiltration Control Dialysate DE… | 1985 |
| * | K850569 | BSM 2000 Dialysis Machine - ModifiedSummary page 1…logy & Urology Class Il, 78 FKP, Single Patient Dialysate Delivery System 21 CFR 876.5820 SUBSTANTIAL EQUIVALENCE! TO: 510 (k) Number Applicant Description K854367, K850569 Modified Organon Teknika HD Secura Dialysis Unit K880459 CD Medical 480 High-Flow Ultrafiltration Control Dialysate DEVICE DESC… | 1985 |
| * | K880459 | 480 High-Flow Ultrafiltration Control DialysateSummary page 1…Delivery System 21 CFR 876.5820 SUBSTANTIAL EQUIVALENCE! TO: 510 (k) Number Applicant Description K854367, K850569 Modified Organon Teknika HD Secura Dialysis Unit K880459 CD Medical 480 High-Flow Ultrafiltration Control Dialysate DEVICE DESCRIPTION: In accordance with section 510(k) for the Federa… | 1988 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | 2004 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2016 | Class I | Z-1531-2016 | Process control | Potential leakage of conductivity sensors of the Dialog Dialysis machines. |
| Apr 1, 2016 | Class I | Z-1534-2016 | Process control | Potential leakage of conductivity sensors of the Dialog Dialysis machines. |
| Apr 1, 2016 | Class I | Z-1532-2016 | Process control | Potential leakage of conductivity sensors of the Dialog Dialysis machines. |
| Apr 1, 2016 | Class I | Z-1535-2016 | Process control | Potential leakage of conductivity sensors of the Dialog Dialysis machines. |
| Apr 1, 2016 | Class I | Z-1533-2016 | Process control | Potential leakage of conductivity sensors of the Dialog Dialysis machines. |
| Apr 1, 2016 | Class I | Z-1536-2016 | Process control | Potential leakage of conductivity sensors of the Dialog Dialysis machines. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K041005 (Gambro Renal Products, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
Volume controlled ultrafiltration and infusion for treatment of renal failure or toxic conditions. This device may be used for high flux hemodialysis.
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/K963440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963440: Dialog Dialysis Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963440
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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