# K123554: Shuntcheck

- Pathway: 510(k) (Traditional)
- Applicant: Neurodx Development, LLC
- Decided: Mar 7, 2013 after 108 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: 1 generation back to K080168 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080168: Shuntcheck - CSF Shunt Flow Detector, Neuro Diagnostic Devices (2008) Summary page 1.

## Indications for use
ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts. ShuntCheck includes Micro-Pumper, a component which may be used to temporarily increase CSF flow in suspected non-flowing, patent shunts during the ShuntCheck test. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.

Source page: https://510kreport.com/device/K123554
Methodology: https://510kreport.com/methodology