510(k) · Cleared
ClearedDBB-05 Hemodialysis Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davita Clinical Research (Trri) · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Oct 30, 2003 as substantially equivalent to K994267 (Fresenius Medical Care, 2000) after a 377-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 377 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921456 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 1 generation backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- This deviceK023509 DBB-05 Hemodialysis Delivery SystemDavita Clinical Research (Trri) · 2003
- Descendant · cites it directly · 3 of its ownK061519 Modification to DBB-05 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2007
- Descendant · cites it directly · 2 of its ownK091978 DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK152938 DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK242155 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD. · 2025
Most influential descendants
Showing 4 of 4 · See all- K061519Modification to DBB-05 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2007 · cites it directly3descendants
- K091978DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2010 · cites it directly2descendants
- K152938DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD. · 2016 · 2 generations on1descendant
- K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −1 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| 0 (this device) | K023509 | DBB-05 Hemodialysis Delivery System | Davita Clinical Research (Trri) | 2003 | — |
| +1 | K061519 | Modification to DBB-05 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2007 | — |
| +1 | K091978 | DBB-06 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2010 | 1 |
| +2 | K152938 | DBB-06 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2016 | 1 |
| +3 | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | Nikkiso CO., LTD. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K994267 | Fresenius 2008KSummary page 1…1 CFR 867.5860 Product KDI Code: Predicate The subject device is substantially equivalent to the Fresenius Device(s): Hemodialysate System, model 2008H, (K994267) manufactured by Fresenius Medical Care North America. Device The subject device is composed of a hydr… | 2000 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K061519 (Nikkiso CO., LTD., 2007) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K994267.
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?
The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023509 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023509: DBB-05 Hemodialysis Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023509
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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