510(k) · Cleared
ClearedFB-U Hemodialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Feb 8, 2017 as substantially equivalent to K131935 (Nipro Medical Corporation, 2013) and 1 other predicate after a 357-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Feb 8, 2017
- Review
- 357 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001283 (2001). 19 ancestors in all, the oldest K872364 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 7 generations between
- 3 generations backK093120 Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM…Baxter Healthcare Corporation - Renal Division · 2010
- 2 generations backK122347 Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation · 2013
- 1 generation backK131935 Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation · 2013
- This deviceK160444 FB-U HemodialyzerNipro Medical Corporation · 2017
Show all 11 generations
- Root · 11 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 10 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 9 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 8 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 7 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 6 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 5 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- 4 generations backK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
- 3 generations backK093120 Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM…Baxter Healthcare Corporation - Renal Division · 2010
- 2 generations backK122347 Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation · 2013
- 1 generation backK131935 Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation · 2013
- This deviceK160444 FB-U HemodialyzerNipro Medical Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −10 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −9 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −8 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −7 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −6 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| −5 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| −4 | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2009 | — |
| −3 | K093120 | Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150… | Baxter Healthcare Corporation - Renal Division | 2010 | — |
| −2 | K122347 | Elisio-H and Elisio-M Hemodialyzers | Nipro Medical Corporation | 2013 | — |
| −1 | K131935 | Elisio-H Hemodialyzer, Elisio-M Hemodialyzer | Nipro Medical Corporation | 2013 | — |
| 0 (this device) | K160444 | FB-U Hemodialyzer | Nipro Medical Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K131935 | Elisio-H Hemodialyzer, Elisio-M HemodialyzerSummary page 4…0 Regulatory Class: II Panel: Gastroenterology/Urology Product Code: KDI Legally marketed substantial equivalent device: Nipro Elisio-M (K131935) Baxter Exeltra (K030974) Description of device: The Nipro FB-U hemodialyzer is a medical device intended for use… | 2013 |
| * | K030974 | Exeltra High Flux Dialyzer, Models 150 & 170Summary page 4…Panel: Gastroenterology/Urology Product Code: KDI Legally marketed substantial equivalent device: Nipro Elisio-M (K131935) Baxter Exeltra (K030974) Description of device: The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney s… | 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 16 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 2 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K131935.
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. 2017, 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?
Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
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/K160444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160444: FB-U Hemodialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160444
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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