510(k) · Cleared
Recalled · 2010Bravo Multi-Modality System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Nov 3, 1999 as substantially equivalent to K905632 (Nicolet Instrument Corp., 1991) and 2 other predicates after a 218-day review. Its family tree reaches back 1 generation to 1988. 1 of the 97 devices in its family, counting itself, has a Class I recall. 93 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 3, 1999
- Review
- 218 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K874685 (1988). 3 ancestors in all. 93 later devices descend from it, 9 citing it directly. 1 of the 97 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK874685 Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 1988
- This deviceK991054 Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 1999
- Descendant · cites it directly · 40 of its ownK031510 Nim-SpineMedtronic Xomed · 2003
- Descendant · cites it directly · 30 of its ownK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 2 generations on · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · cites it directly · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor3 generations on · 2020
Most influential descendants
Showing 5 of 93 · See all- K031510Nim-SpineMedtronic Xomed · 2003 · cites it directly40descendants
- K112052Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · cites it directly30descendants
- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · 2 generations on30descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · cites it directly24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874685 | Trans-Scan 3-D Transcranial Doppler | Carolina Medical Electronics | 1988 | — |
| 0 (this device) | K991054 | Bravo Multi-Modality System | Nicolet Biomedical, Inc. | 1999 | — |
| +1 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| +1 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +2 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +1 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 1 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K905632 | Nicolet Mapleleaf SystemSummary page 1…Nonfetal Ultrasonic Monitor (90JAF) jK N 4 OLT (3) Identification of the legally marketed devices to which equivalence is claimed. 1. Nicolet Spirit EMG/EP (FDA Log No. K905632) 2. Nicolet Voyageur EEG (FDA Log No. K921927) 3. Nicolet/EME Trans-Scan TCD (FDA Log No. K874685) (4) Description of the device… | 1991 |
| * | K921927 | Nicolet VoyageurSummary page 1…(3) Identification of the legally marketed devices to which equivalence is claimed. 1. Nicolet Spirit EMG/EP (FDA Log No. K905632) 2. Nicolet Voyageur EEG (FDA Log No. K921927) 3. Nicolet/EME Trans-Scan TCD (FDA Log No. K874685) (4) Description of the device, including an explanation of how the device f… | 1992 |
| * | K874685 | Trans-Scan 3-D Transcranial DopplerSummary page 1…to which equivalence is claimed. 1. Nicolet Spirit EMG/EP (FDA Log No. K905632) 2. Nicolet Voyageur EEG (FDA Log No. K921927) 3. Nicolet/EME Trans-Scan TCD (FDA Log No. K874685) (4) Description of the device, including an explanation of how the device functions, the scientific concepts, and the significa… | 1988 |
What descends from it? (93)
See all 939 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031510 | Nim-Spine | 2003 | 40 |
| K112052 | Carefusion Nicolet Edx | 2012 | 30 |
| K132694 | Nuvasive NVM5 System | 2014 | 24 |
| K061640 | Integra Mobius Multi-Modality Monitoring System | 2006 | 15 |
| K080217 | Component Neuromonitoring System | 2008 | 14 |
| K082886 | Zoom-100DC | 2009 | 11 |
| K142064 | Galileo NT | 2015 | 2 |
| K020218 | Snap Eeg Monitor | 2002 | 1 |
| K051825 | Cognitrace | 2005 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2010 | Not classified | Z-1256-2010 | Software design | 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 result in the misinterpretation of… |
| Jun 13, 2008 | Not classified | Z-2459-2008 | Software design | 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 the A2 wall plate does not always… |
| Jun 5, 2008 | Not classified | Z-2389-2008 | Nonconforming Material/Component | 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 number 698-625500, with NicoletOne EEG… |
| Aug 25, 2006 | Not classified | Z-0380-2007 | Other | 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 for channel one in all channels on… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K031510 (Medtronic Xomed, 2003) has gone furthest, with 40 descendants of its own.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991054: Bravo Multi-Modality System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991054
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026