# K915546: PS Medical Ventriculostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Dec 30, 1991 after 19 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- 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; 1 cites 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
- K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal (2004), 2 descendants of its own
- K252514: Evac-Mri (2025), 0 descendants of its own
- K241458: Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (2024), 0 descendants of its own

## Recalls of this device
- Jun 17, 2026 · Class II · Z-2768-2026: Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into conta

Source page: https://510kreport.com/device/K915546
Methodology: https://510kreport.com/methodology