510(k) · Cleared
ClearedDBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nikkiso CO., LTD. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on May 15, 2025 as substantially equivalent to K152938 (Nikkiso CO., LTD., 2016) and 1 other predicate after a 296-day review. Its family tree reaches back 12 generations to 1994. 3 of the 29 devices in its family, counting itself, have a Class I recall.
- Decided
- May 15, 2025
- Review
- 296 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K921456 (1994). 28 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet. 3 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 8 generations between
- 3 generations backK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- 2 generations backK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- 1 generation backK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- This deviceK242155 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD. · 2025
Show all 12 generations
- Root · 12 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 11 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 10 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 9 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 8 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- 7 generations backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 6 generations backK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 5 generations backK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- 4 generations backK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- 3 generations backK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- 2 generations backK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- 1 generation backK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- This deviceK242155 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD. · 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 |
|---|---|---|---|---|---|
| −12 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −11 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −10 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −9 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −8 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| −7 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| −6 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| −5 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| −4 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| −3 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| −2 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| −1 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 |
| 0 (this device) | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | Nikkiso CO., LTD. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 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.
3 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 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? (2)
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 |
|---|---|---|---|
| * | K152938 | DBB-06 Hemodialysis Delivery SystemSummary page 6…-06 Hemodialysis Delivery System The primary predicate device for the DBB-06 PRO Hemodialysis System is the DBB-06 Hemodialysis Delivery System cleared under K152938. The EF-02D endotoxin retentive filters used on the DBB-06 PRO hemodialysis delivery system, were originally cleared under… | 2016 |
| * | K231125 | 2008T BlueStar Hemodialysis MachineSummary page 6…Bluestar Hemodialysis Machine The secondary predicate device for the DBB-06 PRO Hemodialysis System is the 2008T BlueStar™ Hemodialysis system cleared under K231125. 510(k) Number K231125 Trade Name: 2008T Bluestar™ Hemodialysis Machine Common Name:… | 2023 |
| † | K222952 | 2008T BlueStar Hemodailysis Machine | 2022 |
| † | K173972 | 2008T BlueStar Hemodialysis Machine | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 2 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
- K083460Dialog with Adimea OptionB. Braun Avitum AG · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 16 Class I recalls
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 4 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 6 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 28 ancestors have a recall of any class; 3 have a Class I recall.
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. 2025, 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 DBB-06 PRO Hemodialysis Delivery System is indicated for hemodialysis prescribed by
physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis
clinics by qualified operators. The DBB-06 PRO Hemodialysis Delivery System is not indicated for
pediatric patients. It is not for home use.
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/K242155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242155: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242155
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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