# K873247: CSF-Flow Control Valve, Ultra Small

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Sep 18, 1987 after 35 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
- 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/K873247
Methodology: https://510kreport.com/methodology