510(k) · Cleared
ClearedNicolet Mapleleaf System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Instrument Corp. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jun 7, 1991 after a 172-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 95 devices in its family, counting itself, has a Class I recall. 94 later devices descend from it.
- Decided
- Jun 7, 1991
- Review
- 172 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 1 citing it directly. 1 of the 95 devices in this family, counting this one, has a Class I recall.
- This deviceK905632 Nicolet Mapleleaf SystemNicolet Instrument Corp. · 1991
- Descendant · cites it directly · 93 of its ownK991054 Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 40 of its ownK031510 Nim-SpineMedtronic Xomed · 2003
- Descendant · 2 generations on · 30 of its ownK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 3 generations on · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor4 generations on · 2020
Most influential descendants
Showing 5 of 94 · See all- K991054Bravo Multi-Modality SystemNicolet Biomedical, Inc. · 1999 · cites it directly93descendants
- K031510Nim-SpineMedtronic Xomed · 2003 · 2 generations on40descendants
- K112052Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 2 generations on30descendants
- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · 3 generations on30descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905632 | Nicolet Mapleleaf System | Nicolet Instrument Corp. | 1991 | — |
| +1 | K991054 | Bravo Multi-Modality System | Nicolet Biomedical, Inc. | 1999 | 4 |
| +2 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| +2 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +3 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +2 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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), 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 GWJ device
- #1 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (94)
See all 941 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991054 | Bravo Multi-Modality System | 1999 | 93 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991054 (Nicolet Biomedical, Inc., 1999) has gone furthest, with 93 descendants of its own.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K905632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K905632: Nicolet Mapleleaf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905632
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026