# K853365: H-H Fifth Ventricle

- Pathway: 510(k) (Traditional)
- Applicant: Holter-Hausner Intl.
- Decided: Sep 5, 1985 after 24 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.
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
- K081942: Neurocath AG (2008), 1 descendant of its own
- K242974: External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (2025), 0 descendants of its own
- K170599: SureFlo EVD Catheter (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K853365
Methodology: https://510kreport.com/methodology