510(k) · Cleared
Recalled · 2005Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Medical Co., Ltd. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 16, 2000 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 16, 2000
- Review
- 119 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 0
31 later devices descend from it, 8 citing it directly.
- This deviceK001250 Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. · 2000
- Descendant · cites it directly · 22 of its ownK041726 High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber…Asahi Medical Co., Ltd. · 2004 · Recalled
- Descendant · cites it directly · 20 of its ownK051187 Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005 · Recalled
- Descendant · 2 generations on · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- Descendant · 3 generations on · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- Descendant · 4 generations on · 12 of its ownK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K041726High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…Asahi Medical Co., Ltd. · 2004 · cites it directly22descendants
- K051187Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005 · cites it directly20descendants
- K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · 2 generations on16descendants
- K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · 3 generations on13descendants
- K152367Optiflux dialyzerFresenius Medical Care North America · 2015 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | Asahi Medical Co., Ltd. | 2000 | — |
| +1 | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer… | Asahi Medical Co., Ltd. | 2004 | 1 |
| +1 | K051187 | Rexeed Series Dialyzers | Asahi Kasei Medical Co., Ltd. | 2005 | 1 |
| +2 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| +3 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| +4 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models… | 2004 | 22 |
| K051187 | Rexeed Series Dialyzers | 2005 | 20 |
| K050603 | Olpur Dialyzer, Model HD 190 | 2005 | 6 |
| K082515 | Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX | 2008 | 1 |
| K162248 | Asahi ViE-U Series Dialyzer | 2017 | 0 |
| K153344 | Asahi REXEED-S Series Dialyzer | 2015 | 0 |
| K121409 | Asahi Rexeed-SX/LX Series Dialyzer | 2013 | 0 |
| K013418 | AM-Bio Extended Range Series Dialyzer, Models Wet and Dry | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2005 | Not classified | Z-0790-05 | Other | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. |
| Oct 1, 2001 | Not classified | Z-0739-04 | Other | Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041726 (Asahi Medical Co., Ltd., 2004) has gone furthest, with 22 descendants of its own.
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 | — |
https://510kreport.com/device/K001250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001250
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026