# K991054: Bravo Multi-Modality System

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Nov 3, 1999 after 218 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874685 (1988). 3 ancestors in all.
93 later devices descend from it; 9 cite it directly.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905632: Nicolet Mapleleaf System, Nicolet Instrument Corp. (1991) Summary page 1.
- K921927: Nicolet Voyageur, Nicolet Instrument Corp. (1992) Summary page 1.
- K874685: Trans-Scan 3-D Transcranial Doppler, Carolina Medical Electronics (1988) Summary page 1.

## Most influential descendants
- K031510: Nim-Spine (2003), 40 descendants of its own
- K112052: Carefusion Nicolet Edx (2012), 30 descendants of its own
- K083124: NIM 3.0 (2009), 30 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own

## Recalls of this device
- Mar 8, 2010 · Not classified · Z-1256-2010: CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may
- Jun 13, 2008 · Not classified · Z-2459-2008: NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to
- Jun 5, 2008 · Not classified · Z-2389-2008: Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part num
- Aug 25, 2006 · Not classified · Z-0380-2007: A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data f

## Indications for use
The Bravo Multi-Modality System is intended to record and display EEG, EP, EMG and TCD data in the clinic and hospital (including the hospital room, operating room, emergency room, intensive care unit, neuro intensive care unit, critical care unit, etc. ) and to import and display data from third-party monitoring devices such as vital signs monitors. It is intended to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

Source page: https://510kreport.com/device/K991054
Methodology: https://510kreport.com/methodology