# K760501: Valve, Standard Model Pudenze Flushing

- Pathway: 510(k) (Traditional)
- Applicant: Heyer Schulte Corp.
- Decided: Aug 30, 1976 after 7 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K153041: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (2016), 0 descendants of its own

## Recalls of this device
- Apr 4, 2012 · Class II · Z-1984-2012: The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure".

Source page: https://510kreport.com/device/K760501
Methodology: https://510kreport.com/methodology