510(k) · Cleared
Recalled · 2005Blood Monitor Pump
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 Sep 9, 1997 as substantially equivalent to K911315 (Baxter Healthcare Corp, 1991) after a 203-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 9, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911315 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK911315 Extracorporeal Blood Pumping Syst for HemofiltratBaxter Healthcare Corp · 1991 · Recalled
- This deviceK970591 Blood Monitor PumpBaxter Healthcare Corp · 1997
- Descendant · cites it directly · 0 of its ownK974652 Blood Monitor Pump with Ultrafiltration ControllerBaxter Healthcare Corp · 1998 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K974652Blood Monitor Pump with Ultrafiltration ControllerBaxter Healthcare Corp · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911315 | Extracorporeal Blood Pumping Syst for Hemofiltrat | Baxter Healthcare Corp | 1991 | 1 |
| 0 (this device) | K970591 | Blood Monitor Pump | Baxter Healthcare Corp | 1997 | — |
| +1 | K974652 | Blood Monitor Pump with Ultrafiltration Controller | Baxter Healthcare Corp | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K911315 | Extracorporeal Blood Pumping Syst for HemofiltratSummary page 1…for Continuous Renal Replacement Blood Monitor Pump for Continuous Renal Replacement High Permeability Hemodialysis System per 21 CFR 876.5860 bm11 Blood Monitor Pump (K911315/A) The bm11a Blood Monitor Pump is designed for use in the following extracorporeal therapies: - Continuous Venovenous Hemofilt… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974652 | Blood Monitor Pump with Ultrafiltration Controller | 1998 | 0 |
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-0680-06 | 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?
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 bm11a Blood Monitor Pump is designed for continuous renal
replacement therapy in patients with acute renal failure, 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/K970591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970591: Blood Monitor Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970591
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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