510(k) · Cleared
ClearedDiapact CRRT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 10, 1998 as substantially equivalent to K900105 (Cobe Laboratories, Inc., 1991) and 1 other predicate after a 432-day review. Its family tree reaches back 1 generation to 1991. 39 later devices descend from it.
- Decided
- Nov 10, 1998
- Review
- 432 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900105 (1991). 2 ancestors in all. 39 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK900105 Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
- This deviceK973322 Diapact CRRTB.Braun Medical, Inc. · 1998
- Descendant · cites it directly · 29 of its ownK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- Descendant · 2 generations on · 28 of its ownK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- Descendant · 3 generations on · 27 of its ownK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- Descendant · 5 generations on · 20 of its ownK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K030470Nxstage System OneNxstage Medical, Inc. · 2003 · cites it directly29descendants
- K041424Nxstage System OneNxstage Medical, Inc. · 2004 · 2 generations on28descendants
- K050525Nxstage System OneNxstage Medical, Inc. · 2005 · 3 generations on27descendants
- K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 4 generations on26descendants
- K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900105 | Cobe Spectra Blood Component Separator Therapeutic | Cobe Laboratories, Inc. | 1991 | — |
| 0 (this device) | K973322 | Diapact CRRT | B.Braun Medical, Inc. | 1998 | — |
| +1 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| +2 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| +3 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| +4 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| +5 | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K900105 | Cobe Spectra Blood Component Separator TherapeuticSummary page 1…y & Urology - Class Ill, 78 KDI, Single Patient Dialysate Delivery System 21 CFR 876.5820 SUBSTANTIAL EQUIVALENCE! TO: - 510 (k) Number _ - | Applicant -~ Description 'K900105 | Cobe Laboratories, Inc. | SPECTRA - Blood Component Separator Therapeutic K946279 Cobe Renal Care Inc. PRISMA - CFM - Continuou… | 1991 |
| * | K946279 | Prisma CFM (Continuous Fluid Management System)Summary page 1….5820 SUBSTANTIAL EQUIVALENCE! TO: - 510 (k) Number _ - | Applicant -~ Description 'K900105 | Cobe Laboratories, Inc. | SPECTRA - Blood Component Separator Therapeutic K946279 Cobe Renal Care Inc. PRISMA - CFM - Continuous Fluid Management System DEVICE DESCRIPTION: In accordance with section 510(k) for… | 1997 |
What descends from it? (39)
See all 393 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?
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?
It is an extracorporeal blood purification system intended to be used for acute renal failure. The system provides high flow continuous renal replacement therapies, emergency intermittent dialysis treatment and plasmapheresis.
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/K973322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973322: Diapact CRRT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973322
Report an extraction error
Are you the manufacturer?
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