# K182073: BcSs-PICNI-2000 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A.
- Decided: Oct 17, 2019 after 442 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: 2 generations back to K914479 (1994). 2 ancestors in all.
2 later devices descend 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)
- K153347: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit, Codman & Shurtleff, Inc. (2016) Summary page 4.

## Most influential descendants
- K201989: B4C System (2021), 1 descendant of its own
- K240821: B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (2024), 0 descendants of its own

## Indications for use
The BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.

Source page: https://510kreport.com/device/K182073
Methodology: https://510kreport.com/methodology