510(k) · Cleared
ClearedAsahi REXEED-S 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 Dec 17, 2015 as substantially equivalent to K001250 (Asahi Medical Co., Ltd., 2000) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 17, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001250 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK153344 Asahi REXEED-S Series DialyzerAsahi Kasei Medical Co., Ltd. · 2015
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) | K153344 | Asahi REXEED-S Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2015 | — |
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? (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 4…Systems, and Urology 21 CFR 876.5860 PREDICATE DEVICE(S): Asahi REXEED-S Series Dialyzer: K001250, August 16, 2000; K041726, July 23, 2004; and K051187, June 8, 2005 DEVICE DESCRIPTION The line of Asahi REXEED-S Series D… | 2000 |
| * | K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…Summary page 4…and Urology 21 CFR 876.5860 PREDICATE DEVICE(S): Asahi REXEED-S Series Dialyzer: K001250, August 16, 2000; K041726, July 23, 2004; and K051187, June 8, 2005 DEVICE DESCRIPTION The line of Asahi REXEED-S Series Dialyzer (hereafter referred t… | 2004 |
| * | K051187 | Rexeed Series DialyzersSummary page 4…and Urology 21 CFR 876.5860 PREDICATE DEVICE(S): Asahi REXEED-S Series Dialyzer: K001250, August 16, 2000; K041726, July 23, 2004; and K051187, June 8, 2005 DEVICE DESCRIPTION The line of Asahi REXEED-S Series Dialyzer (hereafter referred to as REXEED-S) is a family of h… | 2005 |
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 15 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 5 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. 2015, 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-S Series Dialyzer is intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153344: Asahi REXEED-S Series Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153344
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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