510(k) · Cleared
Recalled · Class II · 2025Surdial DX Hemodialysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jul 19, 2019 as substantially equivalent to K083460 (B. Braun Avitum AG, 2010) after a 269-day review. Its family tree reaches back 1 generation to 2010. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jul 19, 2019
- Review
- 269 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083460 (2010). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK083460 Dialog with Adimea OptionB. Braun Avitum AG · 2010 · Recalled (Class I)
- This deviceK182940 Surdial DX Hemodialysis SystemNipro Medical Corporation · 2019
Class I recalls in this family
- K083460 Dialog with Adimea Optiondirect predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083460 | Dialog with Adimea Option | B. Braun Avitum AG | 2010 | Class I |
| 0 (this device) | K182940 | Surdial DX Hemodialysis System | Nipro Medical Corporation | 2019 | — |
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 |
|---|---|---|---|
| * | K083460 | Dialog with Adimea OptionSummary page 4…5860 Product Code: KDI Classification Panel: Gastroenterology/Urology 5.3. Legally Marketed Predicate Device B Braun Dialog+® Hemodialysis System (K083460) is the predicate for the SURDIAL DX Hemodialysis Machine. 5.4. Device Description The SURDIAL DX Hemodialysis System is a singl… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 27, 2025 | Class II | Z-0912-2026 | Device Design | Screw may loosen or fallout of Hemodialysis system |
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.
- K083460Dialog with Adimea OptionB. Braun Avitum AG · 2010 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
What does this lineage say?
- Its one ancestor has a recall, Class I.
- 1 other device also cites its predicate K083460.
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. 2019, 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?
The SURDIAL DX Hemodialysis System is indicated for implementing and monitoring hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182940: Surdial DX Hemodialysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182940
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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