510(k) · Cleared
Recalled · 2006Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-Bio-50,AM-Bio-65, AM-Bio-75, and AM-Bio-100, AM-Bio-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Medical Co., Ltd. · MSE Hemodialyzer, Re-Use, Low Flux
Cleared on May 17, 1999 after a 208-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 3 times.
- Decided
- May 17, 1999
- Review
- 208 days
- Class
- Class II
- Product code
- MSE
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983720 Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models…Asahi Medical Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK013418 AM-Bio Extended Range Series Dialyzer, Models Wet and DryAsahi Medical Co., Ltd. · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K013418AM-Bio Extended Range Series Dialyzer, Models Wet and DryAsahi Medical Co., Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983720 | Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models… | Asahi Medical Co., Ltd. | 1999 | — |
| +1 | K013418 | AM-Bio Extended Range Series Dialyzer, Models Wet and Dry | Asahi Medical Co., Ltd. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MSE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Asahi AM Series Dialyzers Named without a submission number | |
| * | — | Asahi AM-R Series Dialyzers Named without a submission number | |
| * | — | Baxter HT Dialyzers Named without a submission number | |
| * | — | Gambro COBE Centrysystem HG Dialyzers Named without a submission number | |
| * | — | Gambro Alwall GFS Plus Dialyzers Named without a submission number |
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 |
|---|---|---|---|
| K013418 | AM-Bio Extended Range Series Dialyzer, Models Wet and Dry | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2006 | Not classified | Z-0174-2007 | Other | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. |
| Oct 12, 2006 | Not classified | Z-0173-2007 | Other | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. |
| Mar 31, 2005 | Not classified | Z-0788-05 | Other | Exposure 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?
- Of its descendants, K013418 (Asahi Medical Co., Ltd., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MSE devicesMSE Hemodialyzer, Re-Use, Low Flux: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSE
FDA has decided no MSE device since 2007.
Median 510(k) review, days · MSE
Too few MSE 510(k)s in any year since 2007 to give a median.
Recalls per year · MSE
No recall names MSE since 2007.
Adverse event reports per year · MSE
5in 2014
MAUDE reports naming product code MSE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
a. Asahi AM-BIO Series Dialyzers are intended for use for hemodialysts treatment of patients who have chronic renal failure or acute renal failure, b. Asshi AM-BIO 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 Series-Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under…
Read the full statement (327 words)
a. Asahi AM-BIO Series Dialyzers are intended for use for hemodialysts treatment of
patients who have chronic renal failure or acute renal failure,
b. Asshi AM-BIO 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 Series-Dialyzers have been tested in vitro and in confirmatory clinical
studies under single or initial use and under reprocessing and reuse conditions for up to 13
reuse cycles. Based on the resuits from these evaluations, Asahi AM-BJO Series
Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is
practiced, it is recommended that the reuse be done under the conditions as existed in the
in vitro and confirmatory clinical studies as recommended immediately below. It is noted
that the Asahi AM-BIO Series Dialyzers have not been tested for reuse when reprocessed
with agents and/or processes other than these, and the performance of the dialyzers under
other conditions are not known and cannot be recommended. Accordingly:
The reprocessed dialyzer may be used only if the residual Total Cell Volume
{TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets
the acceptance criteria of these instructions for use and the instructions of the
reprocessing system utilized. Furthermore, the policies, instructions, and criteria
of the institution for reuse (e.g., conceming dialyzer performance, residual blood,
and/or dialyzer leakage or damage) should be followed.
The reprocessing agent may be either (1) 4% formaldehyde (also known as
formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for
Dialyzer Reprocessing and Preparation (DRS4" and DPS4 ), manufactured by
Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialvzer
Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
The instructions provided by the manufacturer of the chosen reprocessing agent
must be followed in reprocessing the dialyzer.
The reprocessed dialyzer may be used only on dialysis systems equipped with
volumetric ultrafiitration controllets.
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/K983720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983720: Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-Bio-50,AM-Bio-65, AM-Bio-75, and AM-Bio-100, AM-Bio-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983720
Report an extraction error
Are you the manufacturer?
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