# K091328: Siphonx Gravitational Antisiphon Device

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Jan 22, 2010 after 262 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: 7 generations back to K944222 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011030: Aesculap -Miethke Shunt System, Aesculap, Inc. (2002)
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T, Aesculap, Inc. (2007) Summary page 2.

## Indications for use
The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid (CSF).

Source page: https://510kreport.com/device/K091328
Methodology: https://510kreport.com/methodology