# K854049: Heyer-Schulte Syringo Peritoneal Shunt

- Pathway: 510(k) (Traditional)
- Applicant: American V. Mueller
- Decided: Nov 27, 1985 after 55 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 5 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 28, 2011 · Not classified · Z-1047-201: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Nov 28, 2011 · Not classified · Z-1051-2012: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Nov 28, 2011 · Not classified · Z-1049-2012: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Nov 28, 2011 · Not classified · Z-1048-2012: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Nov 28, 2011 · Not classified · Z-1050-2012: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.

Source page: https://510kreport.com/device/K854049
Methodology: https://510kreport.com/methodology