510(k) · Cleared
ClearedFresenius Ultraflo HPX Hemodialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jan 30, 2004 as substantially equivalent to K002277 (Fresenius Medical Care North America, 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 30, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002277 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK002277 Fresenius Optiflux 200NRFresenius Medical Care North America · 2000 · Recalled
- 1 generation backK031378 Fresenius Ultraflux HemodialyzerFresenius Medical Care North America · 2003
- This deviceK034064 Fresenius Ultraflo HPX HemodialyzerFresenius Medical Care North America · 2004
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K002277 | Fresenius Optiflux 200NRSummary page 1…Class II per §876.5860 C. Predicate Device The predicate devices for the Fresenius Ultraflo HPX Hemodialyzer are: * Fresenius Optiflux 200NR - #K002277 (8/25/00); · Fresenius Ultraflux - #K031378 (5/30/03).… | 2000 |
| * | K031378 | Fresenius Ultraflux HemodialyzerSummary page 1…e Device The predicate devices for the Fresenius Ultraflo HPX Hemodialyzer are: * Fresenius Optiflux 200NR - #K002277 (8/25/00); · Fresenius Ultraflux - #K031378 (5/30/03). 000032… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K002277.
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 Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K034064: Fresenius Ultraflo HPX Hemodialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K034064
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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