510(k) · Cleared
Recalled · 2006High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX
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 Jul 23, 2004 as substantially equivalent to K001250 (Asahi Medical Co., Ltd., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it. It has been recalled once.
- Decided
- Jul 23, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001250 (2000). 22 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK001250 Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. · 2000 · Recalled
- This deviceK041726 High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber…Asahi Medical Co., Ltd. · 2004
- 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
- Descendant · 5 generations on · 9 of its ownK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- 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
- K162488Optiflux dialyzerFresenius Medical Care North America · 2017 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | Asahi Medical Co., Ltd. | 2000 | 2 |
| 0 (this device) | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer… | Asahi Medical Co., Ltd. | 2004 | — |
| +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 |
| +5 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Summary page 2…criteria, and proved that those modifications to be appropriate. Conclusion: Asahi Medical made three modifications to the original APS Series Dialyzers cleared under K001250. All design verification tests based on the result of risk analysis proved that modified APS Series Dialyzers are substantially e… | 2000 |
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2006 | Not classified | Z-0171-2007 | Other | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. |
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?
A. APS Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. B. APS Series Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient. C. APS Series Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse…
Read the full statement (332 words)
A. APS Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
B. APS Series Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
C. APS Series Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi APS Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi APS Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly:
(1) The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instruction for use and the instruction of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
(2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin ® (peroxyacetic acid) in conjunction with the Renatron ® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
(3) The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
(4) The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041726 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041726: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041726
Report an extraction error
Are you the manufacturer?
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