# K954285: Contour Flex Valves (Regular & Small)

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Jan 26, 1996 after 134 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033698: Contour-Flex Valve and Shunt System (2003), 6 descendants of its own
- K172006: Alivio Ventricular Catheter and Flusher System (Alivio System) (2017), 2 descendants of its own
- K221918: ReFlow System Mini (2022), 1 descendant of its own
- K093968: Osv II Low Flow Low Pro Valve (2010), 1 descendant of its own
- K223603: Reflow System Mini and ReFlow Mini Flusher (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K954285
Methodology: https://510kreport.com/methodology