# K020780: Transtar Intracranial Pressure Transducer, Model MX950ICP

- Pathway: 510(k) (Abbreviated)
- Applicant: Medex, Inc.
- Decided: May 20, 2002 after 70 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051599: Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure Evaluation and Relief (Ciper) Kit (2005), 0 descendants of its own

## Recalls of this device
- Sep 24, 2024 · Class II · Z-0183-2025: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar 
- Sep 24, 2024 · Class II · Z-0182-2025: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar 

## Indications for use
The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.

Source page: https://510kreport.com/device/K020780
Methodology: https://510kreport.com/methodology