510(k) · Cleared
ClearedClearflux Dialyzer Reprocessing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novaflux Technologies · LIF Dialyzer Reprocessing System
Cleared on Nov 3, 2010 as substantially equivalent to K860674 (Seratronics, Inc., 1986) and 5 other predicates after a 544-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Nov 3, 2010
- Review
- 544 days
- Class
- Class II
- Product code
- LIF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K834447 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K834447 | Echo MM1000 | Mesa Medical, Inc. | 1984 | — |
| −1 | K024076 | Maky 21.1 Dialyzer Reprocessing System | Hdc Maquinolas, LLC | 2003 | — |
| 0 (this device) | K091360 | Clearflux Dialyzer Reprocessing System | Novaflux Technologies | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 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 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? (6)
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 2…maintains dialyzer reprocessing operations, as well as dialyzer assignments to patients, and dialyzer reprocessing and reuse. Substantially Equivalent Devices: K860674, K914580, K931 336, DRS-4® Dialyzer Reprocessing System, Seratronics, Inc. Agents: Disinfectant - Peracetic Acid… | 1986 |
| * | K914580 | DRS-4 Dialyzer Reprocessing SystemSummary page 2…s dialyzer reprocessing operations, as well as dialyzer assignments to patients, and dialyzer reprocessing and reuse. Substantially Equivalent Devices: K860674, K914580, K931 336, DRS-4® Dialyzer Reprocessing System, Seratronics, Inc. Agents: Disinfectant - Peracetic Acid… | 1992 |
| * | K931336 | DRS 4 Dialyzer Reprocessing SystemSummary page 2…r reprocessing operations, as well as dialyzer assignments to patients, and dialyzer reprocessing and reuse. Substantially Equivalent Devices: K860674, K914580, K931 336, DRS-4® Dialyzer Reprocessing System, Seratronics, Inc. Agents: Disinfectant - Peracetic Acid Cleaning… | 1996 |
| * | K904210 | Renatron II Dialyzer Reprocessing System RS 8330Summary page 2…atronics, Inc. Agents: Disinfectant - Peracetic Acid Cleaning solutions - Bleach Measures: TCV, Leak Rate (pressure decay), Ultrafiltration K904210, Renatron II® Dialyzer Reprocessing System, Minntech Corp. Agents: Peracetic Acid cleaning solution and disinfectant, Formu… | 1990 |
| * | K024076 | Maky 21.1 Dialyzer Reprocessing SystemSummary page 2…Agents: Peracetic Acid cleaning solution and disinfectant, Formula 409 INF rhachine cleaner Measures: TCV, Leak Rate (negative pressure leak) K024076, Makyo 21.1 Dialyzer Reprocessing System, HDC Maquinolas, LLC Agents: "any acceptable cleaning agent" including bleach or p… | 2003 |
| * | K834447 | Echo MM1000Summary page 2…tion process is a result of a hydro- pneumatic design that combines high air pressure with a cleaning agent, forcing particles out of the dialyzer." K834447, ECHO MM-i 000® Automated Dialyzer Reprocessor, Mesa Laboratories, Inc. Agents: Disinfectants - glutaraldehyde, forma… | 1984 |
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 26 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
- None of the 6 ancestors has a 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. 2010, this device’s year, is highlighted.
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 ClearFlux Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4)…
Read the full statement (160 words)
The ClearFlux Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4) volume and leak testing, and (5) disinfecting the dialyzers in accordance with the "AAMI Recommended Practice for Reuse of Hemodialyzers." The ClearFlux System performs the patented in-situ two-phase cleaning cycle during reprocessing, which recovers the total cell volume and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux Dialyzer Reprocessing System is also indicated for performing record keeping of the dialyzer processing operation. The ClearFlux Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula cleaning solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091360 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091360: Clearflux Dialyzer Reprocessing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091360
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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