510(k) · Cleared

Cleared

Asahi ViE-U Series Dialyzer

K162248510(k) TraditionalCleared May 3, 2017266-day reviewClass II21 CFR 876.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Asahi Kasei Medical Co., Ltd. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 3, 2017 as substantially equivalent to K001250 (Asahi Medical Co., Ltd., 2000) and 3 other predicates after a 266-day review. Its family tree reaches back 3 generations to 1995.

Decided: May 3, 2017
Review: 266 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K926373 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK926373 Altra Flux 200 HemodialyzerAlthin Medical AB an Affiliate of Baxter Intl · 1995
2 generations backK992573 AF-220 HemodialyzerAlthin Medical AB · 2000
1 generation backK013550 Clirans E-Series DialyzerTerumo Medical Corp. · 2001
This deviceK162248 Asahi ViE-U Series DialyzerAsahi Kasei Medical Co., Ltd. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K926373	Altra Flux 200 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	1995	—
−2	K992573	AF-220 Hemodialyzer	Althin Medical AB	2000	—
−1	K013550	Clirans E-Series Dialyzer	Terumo Medical Corp.	2001	—
0 (this device)	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
2000	1	0
2001	1	0
2004	1	0

FIG. 1 — Lineage of K162248, 1995–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K001250	Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) Summary page 4 …ode KDI Panel Gastroenterology and Urology III. PREDICATE DEVICES Asahi APS Series Dialyzers: K001250, August 16, 2000, and K041726, July 23, 2004 CLIRANS E-Series Hollow Fiber Dialyzers (Terumo Corporation) K00…	Asahi Medical Co., Ltd.	2000	2
*	K041726	High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models… Summary page 4 …Panel Gastroenterology and Urology III. PREDICATE DEVICES Asahi APS Series Dialyzers: K001250, August 16, 2000, and K041726, July 23, 2004 CLIRANS E-Series Hollow Fiber Dialyzers (Terumo Corporation) K003425, February 1, 2001, and K0…	Asahi Medical Co., Ltd.	2004	1
*	K003425	Clirans E-Series Hollow Fiber Dialyzers Summary page 4 …ahi APS Series Dialyzers: K001250, August 16, 2000, and K041726, July 23, 2004 CLIRANS E-Series Hollow Fiber Dialyzers (Terumo Corporation) K003425, February 1, 2001, and K013550, November 20, 2001 IV DEVICE DESCRIPTION The ViE-U is a high flux hollow fiber hemod…	Terumo Medical Corp.	2001	2
*	K013550	Clirans E-Series Dialyzer Summary page 4 …K001250, August 16, 2000, and K041726, July 23, 2004 CLIRANS E-Series Hollow Fiber Dialyzers (Terumo Corporation) K003425, February 1, 2001, and K013550, November 20, 2001 IV DEVICE DESCRIPTION The ViE-U is a high flux hollow fiber hemodialyzer. The device is sold ste…	Terumo Medical Corp.	2001	—

Also cleared against K001250: 7 other devices →

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 22 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
3 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 devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · KDI

9in 2025

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)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?

ViE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162248: Asahi ViE-U 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/K162248

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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