510(k) · Cleared
Recalled · Class II · 2012Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
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 Oct 3, 2008 as substantially equivalent to K001250 (Asahi Medical Co., Ltd., 2000) and 2 other predicates after a 31-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Oct 3, 2008
- Review
- 31 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001250 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001250 Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. · 2000 · Recalled
- 2 generations backK041726 High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber…Asahi Medical Co., Ltd. · 2004 · Recalled
- 1 generation backK051187 Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005 · Recalled
- This deviceK082515 Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX…Asahi Kasei Medical Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK121409 Asahi Rexeed-SX/LX Series DialyzerAsahi Kasei Medical Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K121409Asahi Rexeed-SX/LX Series DialyzerAsahi Kasei Medical Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | Asahi Medical Co., Ltd. | 2000 | 2 |
| −2 | 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 |
| 0 (this device) | K082515 | Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX… | Asahi Kasei Medical Co., Ltd. | 2008 | — |
| +1 | K121409 | Asahi Rexeed-SX/LX Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 2013 | 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? (3)
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…A.4 Substantial Eguivalence Claimed to Predicate Device APS/REXEED, cleared for commercial distribution via 510(k) Prernarket Notifications K001250 dated August 16, 2000; K04 1726 dated July 23, 2004; and K05 1187 dated June 8,2005. A.5 Device Descrivtion… | 2000 |
| * | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…Summary page 1…Claimed to Predicate Device APS/REXEED, cleared for commercial distribution via 510(k) Prernarket Notifications K001250 dated August 16, 2000; K04 1726 dated July 23, 2004; and K05 1187 dated June 8,2005. A.5 Device Descrivtion The line of Asah… | 2004 |
| * | K051187 | Rexeed Series DialyzersSummary page 1…EXEED, cleared for commercial distribution via 510(k) Prernarket Notifications K001250 dated August 16, 2000; K04 1726 dated July 23, 2004; and K05 1187 dated June 8,2005. A.5 Device Descrivtion The line of Asahi REXEED-SX/LX Dialyzers is a family of high pe… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121409 | Asahi Rexeed-SX/LX Series Dialyzer | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2012 | Class II | Z-2418-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
| Sep 21, 2012 | Class II | Z-2424-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
| Sep 21, 2012 | Class II | Z-2422-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
| Sep 21, 2012 | Class II | Z-2420-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
| Sep 21, 2012 | Class II | Z-2421-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
| Sep 21, 2012 | Class II | Z-2419-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
| Sep 21, 2012 | Class II | Z-2423-2012 | Process change control | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K121409 (Asahi Kasei Medical Co., Ltd., 2013) has gone furthest, with 0 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. 2008, 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?
REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082515: Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082515
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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