510(k) · Cleared
ClearedVenofer Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renal Solutions, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jul 9, 2010 as substantially equivalent to K070739 (Renal Solutions, Inc., 2007) and 1 other predicate after a 197-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 197 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921456 (1994). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 2 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 1 generation backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- This deviceK093964 Venofer PumpRenal Solutions, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK103564 Venofer PumpRenal Solutions, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK121497 Venofer PumpRenal Solutions, Inc. · 2012 · Recalled
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 |
|---|---|---|---|---|---|
| −3 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −2 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −1 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| 0 (this device) | K093964 | Venofer Pump | Renal Solutions, Inc. | 2010 | — |
| +1 | K103564 | Venofer Pump | Renal Solutions, Inc. | 2011 | — |
| +2 | K121497 | Venofer Pump | Renal Solutions, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K070739 | Allient Sorbent Hemodialysis System, Model# 1500Summary page 1…icate device for the Venofer Pump Module is the Heparin Pump, a component of the Allient 1500 Sorbent Hemodialysis System that was cleared by the FDA in 2007 under K070739. The Venofer Pump Module device is substantially equivalent to the predicate device in terms of the following:… | 2007 |
| * | K080964 | Fresenius Model 2008T Hemodialysis MachineSummary page 5…se Statement 510(k) Number (if known): N/A Device Name: Fresenius 2008T Hemodialysis Machine with Venofer Pump Module Indications for Use: Same as K080964 Fresenius 2008T is indicated for acute and chronic dialysis therapy. Prescription Use XAND/O… | 2009 |
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 |
|---|---|---|---|
| K103564 | Venofer Pump | 2011 | 1 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K103564 (Renal Solutions, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K070739.
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?
Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093964: Venofer Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093964
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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