510(k) · Cleared
Recalled · 2006Rexeed Series Dialyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Kasei Medical Co., Ltd. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jun 8, 2005 as substantially equivalent to K001250 (Asahi Medical Co., Ltd., 2000) and 3 other predicates after a 30-day review. Its family tree reaches back 2 generations to 2000. 20 later devices descend from it. It has been recalled once.
- Decided
- Jun 8, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K001250 (2000). 4 ancestors in all. 20 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK001250 Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. · 2000 · Recalled
- 1 generation backK041726 High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber…Asahi Medical Co., Ltd. · 2004 · Recalled
- This deviceK051187 Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005
- Descendant · cites it directly · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- Descendant · 2 generations on · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- Descendant · 3 generations on · 12 of its ownK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- Descendant · 4 generations on · 9 of its ownK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- Descendant · 5 generations on · 6 of its ownK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · cites it directly16descendants
- K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · 2 generations on13descendants
- K152367Optiflux dialyzerFresenius Medical Care North America · 2015 · 3 generations on12descendants
- K162488Optiflux dialyzerFresenius Medical Care North America · 2017 · 4 generations on9descendants
- K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX…Fresenius Medical Care Renal Therapies Group, LLC · 2023 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | Asahi Medical Co., Ltd. | 2000 | 2 |
| −1 | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer… | Asahi Medical Co., Ltd. | 2004 | 1 |
| 0 (this device) | K051187 | Rexeed Series Dialyzers | Asahi Kasei Medical Co., Ltd. | 2005 | — |
| +1 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| +2 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| +3 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
| +4 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 4 |
| +5 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 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? (4)
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 1…fibers to the crimped was implemented. The REXEED dialyzers with crimped hollow fibers is added to the existing APS Series Dialyzers (hereafter called APS) cleared under K001250 and; (2) the REXEED dialyzers membrane surface area ranges from 1.5m 2 to 2.5m 2, while that of APS ranges from 0.8 m 2 to 2.1 m… | 2000 |
| * | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…Summary page 1…e or chronic renal failure. REXEED-U/S are intended for single use and REXEED-UR/R for reuse. This is the same intended use as the existing APS cleared under K001250 and K041726, with the excwtion of using mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin ) as reprocessing agent. REXEED… | 2004 |
| * | K003498 | Fresenius Optiflux 200ASummary page 2…nciple of operation, technology, materials, specifications, and performance to the existing APS cleared under K001250 and K041726, Fresenius Optiflux F200A cleared under K003498, and Gambro Polyflux 24S and Polyflux 24R cleared under K010667, with the exception of using mixture of hydrogen peroxide and per… | 2001 |
| * | K010667 | Gambro Polyflux 24S, Gambro Polyflux 24RSummary page 2…performance to the existing APS cleared under K001250 and K041726, Fresenius Optiflux F200A cleared under K003498, and Gambro Polyflux 24S and Polyflux 24R cleared under K010667, with the exception of using mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®). REXEED Series Dialyzers… | 2001 |
What descends from it? (20)
See all 204 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-0172-2007 | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K082414 (Fresenius Medical Care North America, 2008) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K001250.
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. REXEED Series Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. B. REXEED 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. REXEED Series Dialyzers have been tested in-vitro and under single or initial use conditions and REXEED-UR/R Series Dialyzers under reprocessing and reuse…
Read the full statement (298 words)
A. REXEED Series Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED 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. REXEED Series Dialyzers have been tested in-vitro and under single or initial use conditions and REXEED-UR/R Series Dialyzers under reprocessing and reuse conditions for up to 15t use cycles. Based on the results from these evaluations, REXEED-UR/R 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 as conditions as existed in the in vitro and confirmatory clinical studies recommended immediately below. It is noted that REXEED-UR/R 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 mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®) 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/K051187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051187: Rexeed Series Dialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051187
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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