510(k) · Cleared
Recalled · 2005Blood Monitor Pump with Ultrafiltration Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jul 10, 1998 as substantially equivalent to K970591 (Baxter Healthcare Corp, 1997) and 1 other predicate after a 210-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.
- Decided
- Jul 10, 1998
- Review
- 210 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911315 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK911315 Extracorporeal Blood Pumping Syst for HemofiltratBaxter Healthcare Corp · 1991 · Recalled
- 1 generation backK970591 Blood Monitor PumpBaxter Healthcare Corp · 1997 · Recalled
- This deviceK974652 Blood Monitor Pump with Ultrafiltration ControllerBaxter Healthcare Corp · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911315 | Extracorporeal Blood Pumping Syst for Hemofiltrat | Baxter Healthcare Corp | 1991 | 1 |
| −1 | K970591 | Blood Monitor Pump | Baxter Healthcare Corp | 1997 | 1 |
| 0 (this device) | K974652 | Blood Monitor Pump with Ultrafiltration Controller | Baxter Healthcare Corp | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K970591 | Blood Monitor PumpSummary page 1…Blood Monitor Pump with Ultrafiltration Controlelr for Continuous Renal Replacement High Permeability Hemodialysis System per 21 CFR 876.5860 bm11a Blood Monitor Pump (K970591), PRISMA™ System (K946279) The bm25 Blood Monitor Pump is designed for use in Continuous Renal Replacement Therapy The bm25 Blo… | 1997 |
| * | K946279 | Prisma CFM (Continuous Fluid Management System)Summary page 1…ltrafiltration Controlelr for Continuous Renal Replacement High Permeability Hemodialysis System per 21 CFR 876.5860 bm11a Blood Monitor Pump (K970591), PRISMA™ System (K946279) The bm25 Blood Monitor Pump is designed for use in Continuous Renal Replacement Therapy The bm25 Blood Monitor Pump is designe… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2005 | Not classified | Z-0679-06 | Other | Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
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 bm 25 Blood Monitor Pump with Ultrafiltration Controller is indicated for continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload as prescribed by a physician.
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/K974652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974652: Blood Monitor Pump with Ultrafiltration Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974652
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