# K083378: Synergy

- Pathway: 510(k) (Special)
- Applicant: Innerspace, Inc.
- Decided: Sep 29, 2009 after 319 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: 4 generations back to K002765 (2000). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072379: MPS Oxiport and MPS Oxiport Plus, Innerspace, Inc. (2008) Summary page 1.

## Most influential descendants
- K161010: HICP200 Patient/Monitor Interconnect Cable (2016), 0 descendants of its own

## Indications for use
The use of a Trilogy system by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from one or more parameters may be deemed useful in providing optimum patient management.

Source page: https://510kreport.com/device/K083378
Methodology: https://510kreport.com/methodology