# K940415: Horizon 9000 WS

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Inc.
- Decided: Jan 6, 1995 after 343 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K991775: Modification to Computerized Catheterization Laboratory - Horizon 9000 WS (1999), 5 descendants of its own
- K032997: Modification to: Horizon 9000WS (2003), 4 descendants of its own
- K081484: Horizon Xvu (2008), 1 descendant of its own
- K091165: Horizon Xvu (2009), 0 descendants of its own
- K070254: Horizon SE (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K940415
Methodology: https://510kreport.com/methodology