# K831678: P-S Medical CSF-Flow Control Valve-Bur

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Jun 24, 1983 after 32 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K082127: Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635 (2008), 1 descendant of its own
- K083076: Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836 (2008), 0 descendants of its own
- K042198: PS Medical Neurosurgical Implants (2004), 0 descendants of its own

## Recalls of this device
- Jan 11, 2021 · Class II · Z-1117-2021: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

Source page: https://510kreport.com/device/K831678
Methodology: https://510kreport.com/methodology