510(k) · Cleared
Recalled · Class I · 2022Dialog with Adimea Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Avitum AG · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Feb 18, 2010 after a 454-day review. The FDA summary names its predicate without a number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 8 times, including 6 Class I recalls.
- Decided
- Feb 18, 2010
- Review
- 454 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 8 (6 Class I)
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK083460 Dialog with Adimea OptionB. Braun Avitum AG · 2010
- Descendant · cites it directly · 1 of its ownK152938 DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK242155 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD. · 2025
- Descendant · cites it directly · 0 of its ownK182940 Surdial DX Hemodialysis SystemNipro Medical Corporation · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K152938DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2016 · cites it directly1descendant
- K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD. · 2025 · 2 generations on0descendants
- K182940Surdial DX Hemodialysis SystemNipro Medical Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083460 | Dialog with Adimea Option | B. Braun Avitum AG | 2010 | — |
| +1 | K152938 | DBB-06 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2016 | 1 |
| +2 | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | Nikkiso CO., LTD. | 2025 | — |
| +1 | K182940 | Surdial DX Hemodialysis System | Nipro Medical Corporation | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | — | Dialog+® Hemodialysis System Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2022 | Class II | Z-0873-2022 | Process control | Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on… |
| Jan 28, 2022 | Class II | Z-0872-2022 | Process control | Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on… |
| 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 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152938 (Nikkiso CO., LTD., 2016) has gone furthest, with 1 descendant 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. 2010, this device’s year, is highlighted.
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?
This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.
The following types ‘of renal replacement therapy can be carried out with the Dialog+ System:
Hemodialysis (HD) with or without phases of pure ultrafiltration —
* High flux hemodialysis
* Low 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/K083460 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083460: Dialog with Adimea Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083460
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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