510(k) · Cleared
ClearedReflow System Mini and ReFlow Mini Flusher
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anuncia Medical, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Dec 29, 2022 as substantially equivalent to K221918 (Anuncia Medical, Inc., 2022) after a 27-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Dec 29, 2022
- Review
- 27 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954285 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK954285 Contour Flex Valves (Regular & Small)Radionics, Inc. · 1996
- 3 generations backK033698 Contour-Flex Valve and Shunt SystemIntegra Neurosciences Implants S.A. · 2003 · Recalled
- 2 generations backK172006 Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc. · 2017
- 1 generation backK221918 ReFlow System MiniAnuncia Medical, Inc. · 2022
- This deviceK223603 Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954285 | Contour Flex Valves (Regular & Small) | Radionics, Inc. | 1996 | — |
| −3 | K033698 | Contour-Flex Valve and Shunt System | Integra Neurosciences Implants S.A. | 2003 | 1 |
| −2 | K172006 | Alivio Ventricular Catheter and Flusher System (Alivio System) | Alcyone Lifesciences, Inc. | 2017 | — |
| −1 | K221918 | ReFlow System Mini | Anuncia Medical, Inc. | 2022 | — |
| 0 (this device) | K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | 2022 | — |
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 JXG? 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K221918 | ReFlow System MiniSummary page 4…Class II Product Code and Regulation: JXG, 21CFR 882.5550 III. PREDICATE DEVICE Primary Predicate ReFlow® System Mini (K221918) This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The ReFlow® Sy… | 2022 |
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 4 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ReFlow® System Mini and the ReFlow® Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore…
Read the full statement (163 words)
The ReFlow® System Mini and the ReFlow® Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter’s relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction, and instruction of the treating physician, the ReFlow Mini Flusher may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223603: Reflow System Mini and ReFlow Mini Flusher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223603
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