# K961859: Novus Standard and Pediatric Valves

- Pathway: 510(k) (Traditional)
- Applicant: Integra Neurocare, LLC
- Decided: Dec 16, 1996 after 216 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020728: Miethke Shunt System (2002), 2 descendants of its own
- K974708: Gemini Standard and Mini Valves (1998), 1 descendant of its own
- K242003: XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (2024), 0 descendants of its own
- K200950: Ventricular Catheter (2020), 0 descendants of its own
- K153041: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K961859
Methodology: https://510kreport.com/methodology