# K161010: HICP200 Patient/Monitor Interconnect Cable

- Pathway: 510(k) (Traditional)
- Applicant: Innerspace Neuro Solutions, Inc.
- Decided: Oct 20, 2016 after 192 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
Longest line of descent: 5 generations back to K002765 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083378: Synergy, Innerspace, Inc. (2009) Summary page 5.
- K003759: Aesculap Spiegelberg Brain Pressure Monitor, Aesculap, Inc. (2001) Summary page 5.

## Indications for use
The HICP200 is designed for use with any Hummingbird catheter. Together, they comprise a system that is indicated for use in those conditions where continuous monitoring of ICP is required. As dictated by clinical judgment, direct measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular locations.

Source page: https://510kreport.com/device/K161010
Methodology: https://510kreport.com/methodology