# K040021: Shuntcheck (Prometheus 1)

- Pathway: 510(k) (Traditional)
- Applicant: Samuel Neff M.D.
- Decided: Nov 2, 2004 after 301 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ShuntCheck is indicated for the detection of flow in implanted silastic cerebrospinal fluid (CSF) shunts. ShuntCheck must be used by a qualified neurosurgeon according to instructions. 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/K040021
Methodology: https://510kreport.com/methodology