510(k) · Cleared
ClearedAsahi AM-R Series Dialyzers
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 Sep 30, 1997 as substantially equivalent to K892374 (Asahi Medical Co., Ltd., 1989) and 1 other predicate after a 222-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Sep 30, 1997
- Review
- 222 days
- Class
- Class II
- Product code
- MSE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892374 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK892374 New AM-Series DialyzersAsahi Medical Co., Ltd. · 1989
- This deviceK970650 Asahi AM-R Series DialyzersAsahi Medical Co., Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK991512 Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-XAsahi Medical Co., Ltd. · 1999 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K991512Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-XAsahi Medical Co., Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892374 | New AM-Series Dialyzers | Asahi Medical Co., Ltd. | 1989 | — |
| 0 (this device) | K970650 | Asahi AM-R Series Dialyzers | Asahi Medical Co., Ltd. | 1997 | — |
| +1 | K991512 | Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X | Asahi Medical Co., Ltd. | 1999 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K892374 | New AM-Series DialyzersSummary page 3…s of fabrication, and manufacturing of the Asahi AM-R Series Dialyzers remain unchanged from the Asahi AM-Series Dialyzers cleared by FDA for marketing in the U.S. under K892374 and K892375. Therefore, from the perspective of technological characteristics, the AM-R Series Dialyzers under this 510(k) are id… | 1989 |
| * | K892375 | Modified AM-Series DialyzersSummary page 3…tion, and manufacturing of the Asahi AM-R Series Dialyzers remain unchanged from the Asahi AM-Series Dialyzers cleared by FDA for marketing in the U.S. under K892374 and K892375. Therefore, from the perspective of technological characteristics, the AM-R Series Dialyzers under this 510(k) are identical to t… | 1989 |
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 |
|---|---|---|---|
| K991512 | Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-X | 1999 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K991512 (Asahi Medical Co., Ltd., 1999) 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?
Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is…
Read the full statement (293 words)
Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R 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-R 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:
(1) 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 the instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
(2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4™ and DPS4™) manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc.
(3) The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
(4) The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
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/K970650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970650: Asahi AM-R Series Dialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970650
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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