510(k) · Cleared
Recalled · Class II · 2021DBB-06 Hemodialysis Delivery System
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 Mar 25, 2010 as substantially equivalent to K023509 (Davita Clinical Research (Trri), 2003) and 3 other predicates after a 267-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 25, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K921456 (1994). 8 ancestors in all, the oldest K872291 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 3 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 2 generations backK023509 DBB-05 Hemodialysis Delivery SystemDavita Clinical Research (Trri) · 2003
- 1 generation backK061519 Modification to DBB-05 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2007
- This deviceK091978 DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −3 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −2 | K023509 | DBB-05 Hemodialysis Delivery System | Davita Clinical Research (Trri) | 2003 | — |
| −1 | K061519 | Modification to DBB-05 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2007 | — |
| 0 (this device) | K091978 | DBB-06 Hemodialysis Delivery System | Nikkiso CO., LTD. | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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.
Planning a device in KDI? 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? (4)
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 |
|---|---|---|---|
| * | K023509 | DBB-05 Hemodialysis Delivery SystemSummary page 1…ith or Without Sealed Dialysate System e. Predicate devices The DBB-06 HEMODIALYsis DELIVERY SYSTEM is substantially equivalent to: 510(k): K023509 Trade name: DBB-05 Hemodialysis Delivery System Product code: KDI 510(k):… | 2003 |
| * | K061519 | Modification to DBB-05 Hemodialysis Delivery SystemSummary page 1…510(k): K023509 Trade name: DBB-05 Hemodialysis Delivery System Product code: KDI 510(k): K061519 Trade name: Modification to DBB-05 Hemodialysis Delivery System Product code: KDI f. Descrip… | 2007 |
| * | K972470 | Crit-Line Monitor (Clmiii)Summary page 7…(BVM), NIKKISO CO., LTD. concludes that the Blood Volume Monitor (BVM) performed as well as and is substantially equivalent to the CRIT-LINE Monitor mI (CLMIH (1K972470) and does not raise any new questions regarding safety or effectiveness. Non-Invasive Blood Pressure CNIBP) measurement… | 1997 |
| * | K973637 | Press-Mate AdvantageSummary page 7…generation block * Blood pressure determination block The M2 100 was developed using similar technology of the predicate device, the Press-Mate Advantage (K(973637). All three (3) NIBPs, the M2500, M2100 and the Press-Mate Advantage are manufactured by Cohin Corporation, which merged with… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152938 | DBB-06 Hemodialysis Delivery System | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2021 | Class II | Z-0456-2022 | Under Investigation by firm | Device lacks premarket approval. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K152938 (Nikkiso CO., LTD., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K023509.
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?
The DBB-06 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 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091978 · printed Nov 3, 2026
Cite this page
510(k) Report. “K091978: DBB-06 Hemodialysis Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K091978
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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