510(k) Report

510(k) · Cleared

Recalled · 2005

AM-Bio Extended Range Series Dialyzer, Models Wet and Dry

K013418510(k) TraditionalCleared Jul 9, 2002267-day reviewClass II21 CFR 876.5860Recalls 1

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

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

Cleared on Jul 9, 2002 as substantially equivalent to K983720 (Asahi Medical Co., Ltd., 1999) and 2 other predicates after a 267-day review. Its family tree reaches back 1 generation to 1989. It has been recalled once.

Decided
Jul 9, 2002
Review
267 days
Class
Class II
Product code
KDI
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K892262 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1999: 1 other ancestorK892262 · Fresenius Hemoflow, F40M, F50M, F60M & F80M · Fresenius USA, Inc. · 19891985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K892262 · Fresenius Hemoflow, F40M, F50M, F60M & F80M · Fresenius USA, Inc. · 19890
  1. Root · 1 generation backK892262 Fresenius Hemoflow, F40M, F50M, F60M & F80MFresenius USA, Inc. · 1989
  2. This deviceK013418 AM-Bio Extended Range Series Dialyzer, Models Wet and DryAsahi Medical Co., Ltd. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K892262Fresenius Hemoflow, F40M, F50M, F60M & F80MFresenius USA, Inc.1989—
0 (this device)K013418AM-Bio Extended Range Series Dialyzer, Models Wet and DryAsahi Medical Co., Ltd.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
FIG. 1 — Lineage of K013418, 1989–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K983720Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-Bio-50,AM-Bio-65…
Summary page 1
…IE ON DEVICE Asahi AM-E10 Extended Range Series Dialyzers (AM-BIO-HX S ~ X ~ E S ) IDENTIFICATION OF PREDICATE DEVICES Asahi AM-BIO Series Dialyzers (K983720) Asahi APS Series Dialyzer (KOO1250) Fresenius Hemoflow (K892262) DESCRIPTION OF THE DEVICE The line o…
Asahi Medical Co., Ltd.19993
*K001250Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd.20002
*K892262Fresenius Hemoflow, F40M, F50M, F60M & F80M
Summary page 1
…X ~ E S ) IDENTIFICATION OF PREDICATE DEVICES Asahi AM-BIO Series Dialyzers (K983720) Asahi APS Series Dialyzer (KOO1250) Fresenius Hemoflow (K892262) DESCRIPTION OF THE DEVICE The line of Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) is a fa…
Fresenius USA, Inc.1989—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2005Not classifiedZ-0789-05OtherExposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.

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.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

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

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
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

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

What is it indicated for?

a. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. b. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient. c. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for single…

Read the full statement (122 words)

a. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.

b. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient.

c. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for single use only.

d. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

e. The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.

Indications for use as stated in the FDA summary.

More from Asahi Medical Co., Ltd.

16 FDA decisions under this applicant name. See the company

  • K041726High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EXAsahi Medical Co., Ltd. · 20041 recall
  • K001250Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. · 20002 recalls
  • K991512Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-XAsahi Medical Co., Ltd. · 19991 recall
  • K983720Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-Bio-50,AM-Bio-65, AM-Bio-75, and…Asahi Medical Co., Ltd. · 19993 recalls
  • K970650Asahi AM-R Series DialyzersAsahi Medical Co., Ltd. · 1997

Recent decisions in KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K013418 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013418: AM-Bio Extended Range Series Dialyzer, Models Wet and Dry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013418

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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