# K221918: ReFlow System Mini

- Pathway: 510(k) (Traditional)
- Applicant: Anuncia Medical, Inc.
- Decided: Sep 29, 2022 after 90 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954285 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172006: Alivio Ventricular Catheter and Flusher System (Alivio System), Alcyone Lifesciences, Inc. (2017) Summary page 4.

## Most influential descendants
- K223603: Reflow System Mini and ReFlow Mini Flusher (2022), 0 descendants of its own

## Indications for use
The ReFlow System Mini, used as components of a shunt system, is 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 Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the ReFlow Ventricular Catheter to unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini is 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 System Mini 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.

Source page: https://510kreport.com/device/K221918
Methodology: https://510kreport.com/methodology