# K201989: B4C System

- Pathway: 510(k) (Traditional)
- Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A.
- Decided: Oct 8, 2021 after 448 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: 3 generations back to K914479 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182073: BcSs-PICNI-2000 Sensor, Braincare Desenvolvimento E Inovacao Tecnologica S.A. (2019) Summary page 4.

## Most influential descendants
- K240821: B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (2024), 0 descendants of its own

## Indications for use
The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulses) for interpretation. Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.

Source page: https://510kreport.com/device/K201989
Methodology: https://510kreport.com/methodology