# K003759: Aesculap Spiegelberg Brain Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 28, 2001 after 204 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813459 (1982). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/), Camino Neurocare, Inc. (1996) Summary page 2.
- (no number) Codman Intracranial Pressure Monitor (991222): named in the summary without a submission number

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

## Recalls of this device
- Dec 29, 2009 · Class II · Z-2888-2016: In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to

## Indications for use
The Aesculap® - Spiegelberg Brain Pressure Monitoring System is indicated for use in those conditions where continuous monitoring of intracranial pressure is required. As dictated by clinical judgment, direct measurement of intracranial pressure (ICP) may be obtained from subdural, parenchymal or intraventricular probe locations.

Source page: https://510kreport.com/device/K003759
Methodology: https://510kreport.com/methodology