510(k) · Cleared
ClearedArm Automatic Reprocessing Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcavis International Incorporated · LIF Dialyzer Reprocessing System
Cleared on Jul 15, 2002 as substantially equivalent to K860674 (Seratronics, Inc., 1986) after a 249-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 15, 2002
- Review
- 249 days
- Class
- Class II
- Product code
- LIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860674 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK860674 DRS-4 Dialyzer Reprocessing SystemSeratronics, Inc. · 1986
- This deviceK013713 Arm Automatic Reprocessing MachineAlcavis International Incorporated · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860674 | DRS-4 Dialyzer Reprocessing System | Seratronics, Inc. | 1986 | — |
| 0 (this device) | K013713 | Arm Automatic Reprocessing Machine | Alcavis International Incorporated | 2002 | — |
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 LIF? 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? (1)
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 |
|---|---|---|---|
| * | K860674 | DRS-4 Dialyzer Reprocessing SystemSummary page 1…tem, panel 78, procode LIF, unclassified Legally Marketed Device claiming Substantial Equivalence to, §807.92(a)(3): Seratronic DRS-4 Dialyzer Reprocessing System, K860674 Description of Device, $807.92(a)(4): The Amuchina ARM Automatic [Dialyzer] Reprocessing Machine is a stand alone device… | 1986 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K860674.
How does its category compare?
All LIF devicesLIF Dialyzer Reprocessing System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIF
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LIF
Too few LIF 510(k)s in any year since 2007 to give a median.
Recalls per year · LIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIF
1in 2017
MAUDE reports naming product code LIF, 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 | 3 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 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?
The Amuchina Automatic Reprocessing Machine (ARM) is a device designed for both (a) reprocessing hemodialyzers for reuse, and (b) preprocessing hemodialyzers prior to first use. Reprocessed hemodialyzer will be reused on the same patient on who originally used the hemodialyzer. Both the reprocessing and preprocessing procedures use peracetic acid/hydrogen peroxide based disinfectant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013713 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013713: Arm Automatic Reprocessing Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013713
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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