510(k) · Cleared
ClearedAsahi Rexeed-SX/LX Series Dialyzer
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 Feb 6, 2013 as substantially equivalent to K001250 (Asahi Medical Co., Ltd., 2000) and 3 other predicates after a 271-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Feb 6, 2013
- Review
- 271 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K001250 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK001250 Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. · 2000 · Recalled
- 3 generations backK041726 High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber…Asahi Medical Co., Ltd. · 2004 · Recalled
- 2 generations backK051187 Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005 · Recalled
- 1 generation backK082515 Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX…Asahi Kasei Medical Co., Ltd. · 2008 · Recalled
- This deviceK121409 Asahi Rexeed-SX/LX Series DialyzerAsahi Kasei Medical Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | Asahi Medical Co., Ltd. | 2000 | 2 |
| −3 | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer… | Asahi Medical Co., Ltd. | 2004 | 1 |
| −2 | K051187 | Rexeed Series Dialyzers | Asahi Kasei Medical Co., Ltd. | 2005 | 1 |
| −1 | K082515 | Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX… | Asahi Kasei Medical Co., Ltd. | 2008 | 7 |
| 0 (this device) | 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 |
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…A.4 Substantial Equivalence Claimed to Predicate Device APS/REXEED, cleared for commercial distribution via 5 10(k) Premarket Notifications K001250 dated August 16, 2000; K041726 dated July 23, 2004; KOSI 1187 dated June 8, 2005; and K0825 15, dated October 3, 20… | 2000 |
| * | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…Summary page 1…aimed to Predicate Device APS/REXEED, cleared for commercial distribution via 5 10(k) Premarket Notifications K001250 dated August 16, 2000; K041726 dated July 23, 2004; KOSI 1187 dated June 8, 2005; and K0825 15, dated October 3, 2008. A.5 Device Descr… | 2004 |
| * | K051187 | Rexeed Series DialyzersSummary page 2…appropriate. A.8 Conclusion: Asahi made modifications to the REXEED-SX/LX Series Dialyzer cleared under KOO01250, K041726, K051 187, and K082515, resulting in the modified REXEEfl- SX/LX Series Dialyzer. The information and data provided in this Sp… | 2005 |
| * | K082515 | Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXSummary page 1…istribution via 5 10(k) Premarket Notifications K001250 dated August 16, 2000; K041726 dated July 23, 2004; KOSI 1187 dated June 8, 2005; and K0825 15, dated October 3, 2008. A.5 Device Description The line of Asahi REXEED-SX/LX Series Dialyzer is a fami… | 2008 |
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 13 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 6 ancestors have a recall of any class.
- 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. 2013, 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?
A. REXEED-SX/LX Dialyzers is intended for use for hernodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED SX/L-X Dialyzers must be used in accordance with the instructions for a physician familiar with hemnodialysis and familiar with the conditions of the patient.
C. REXEED SXILX Dialyzers have been tested in vitro under single use conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121409: Asahi Rexeed-SX/LX Series Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121409
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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