# K010422: Act II Icp Monitoring System and Ventricular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innerspace, Inc.
- Decided: Jun 28, 2001 after 136 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- 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; 1 cites 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013005: Act 11 MP Ventricular Catheter (2002), 4 descendants of its own
- K041838: MPS (or MPS-T) (2005), 3 descendants of its own
- K072379: MPS Oxiport and MPS Oxiport Plus (2008), 2 descendants of its own
- K083378: Synergy (2009), 1 descendant of its own
- K161010: HICP200 Patient/Monitor Interconnect Cable (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K010422
Methodology: https://510kreport.com/methodology