# K914479: Microsensor Intracranial Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Mar 7, 1994 after 881 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980380: Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite MS (1999), 27 descendants of its own
- K013930: Neurosensor (2002), 22 descendants of its own
- K050702: Neurosystems 1TM Monitor (2005), 17 descendants of its own
- K061640: Integra Mobius Multi-Modality Monitoring System (2006), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own

## Recalls of this device
- Apr 11, 2023 · Class II · Z-1614-2023: Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedu
- Oct 25, 2011 · Not classified · Z-0706-2012: Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
- Oct 25, 2011 · Not classified · Z-0707-2012: Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.

Source page: https://510kreport.com/device/K914479
Methodology: https://510kreport.com/methodology