510(k) · Cleared
ClearedClirans E-Series Dialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 20, 2001 as substantially equivalent to K003425 (Terumo Medical Corp., 2001) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Nov 20, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926373 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK926373 Altra Flux 200 HemodialyzerAlthin Medical AB an Affiliate of Baxter Intl · 1995
- 1 generation backK992573 AF-220 HemodialyzerAlthin Medical AB · 2000
- This deviceK013550 Clirans E-Series DialyzerTerumo Medical Corp. · 2001
- Descendant · cites it directly · 0 of its ownK162248 Asahi ViE-U Series DialyzerAsahi Kasei Medical Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162248Asahi ViE-U Series DialyzerAsahi Kasei Medical Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926373 | Altra Flux 200 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | 1995 | — |
| −1 | K992573 | AF-220 Hemodialyzer | Althin Medical AB | 2000 | — |
| 0 (this device) | K013550 | Clirans E-Series Dialyzer | Terumo Medical Corp. | 2001 | — |
| +1 | K162248 | Asahi ViE-U Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K003425 | Clirans E-Series Hollow Fiber DialyzersSummary page 1…lness. This device is indicated for single use only. Note: This is the same intended use as the predicate device — CLIRANS® E-Series Hollow Fiber Dialyzer cleared under K003425. C. Device Descrtptton The 2.0 m*> CLIRANS® E and EE Series dialyzers that are the subject of this 510(k) are a larger size (la… | 2001 |
| * | K992573 | AF-220 HemodialyzerSummary page 3…, technology/principles of operation, materials and performance to the CLIRANS® E-Series dialyzers cleared under K003425 and to the Althin AF-220 dialyzers cleared under K992573. Differences between the devices do not raise any significant or new issues of safety or effectiveness. J. Submitter Information… | 2000 |
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 |
|---|---|---|---|
| K162248 | Asahi ViE-U Series Dialyzer | 2017 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K162248 (Asahi Kasei Medical Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K003425.
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?
The CLIRANS® E-series Hollow Fiber Dialyzers are indicated for use whenever a patient is found to be in acute or chronic renal failure and hemodialysis is prescribed by a physician. The device should be used only at the direction of a physician who has evaluated all of the pertinent features of the patient’s illness. This device is indicated for single use only.
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/K013550 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013550: Clirans E-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/K013550
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026