# K113088: Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S (Icp Only)

- Pathway: 510(k) (Traditional)
- Applicant: Innerspace, Inc.
- Decided: May 2, 2012 after 196 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: 1 generation back to K013705 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013705: Act Iii Ventricular Catheter, Innerspace, Inc. (2002) Summary page 1.

## Indications for use
The use of the Hummingbird H900DS Subdural Catheter is indicated for direct measurement of intracranial pressure and/or drainage of CSF in the subdural space. The use of the Hummingbird H800S Subdural Catheter is indicated for direct measurement of intracranial pressure in the subdural space.

Source page: https://510kreport.com/device/K113088
Methodology: https://510kreport.com/methodology