510(k) · Cleared
ClearedNeurovision JJB System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Oct 29, 2007 as substantially equivalent to K062765 (Nuvasive, Inc., 2007) and 2 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Oct 29, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K842956 (1984). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 3 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 2 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 1 generation backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- This deviceK072343 Neurovision JJB SystemNuvasive, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −3 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −2 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −1 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| 0 (this device) | K072343 | Neurovision JJB System | Nuvasive, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 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.
Planning a device in GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 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 |
|---|---|---|---|
| * | K062765 | Modification to Nuvasive Neurovision JJB SystemSummary page 1…e Class: Class LI Classification: §874.1820, §882.1870 Product Code: 77ETN, 84GWF 5 10O(k) Number: K062765 Trade or Proprietary Name: DS7A Constant Current High Voltage Stimulator Manufacturer: Digitimer, L… | 2007 |
| * | K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High…Summary page 1…onse Device Class: Class II Classification: §882.1870 Product Code: 84GWF 510O(k) Number: K051357 Page - 2 -… | 2005 |
| * | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationSummary page 2…Device Class: Class II Classification: §882.1400 Product Code: GWQ, GWE, GWF, GWJ 510(k) Number: K032741 D. Device Description The NeuroVision JJB System consists of a Patient Module, a Control Unit comprised of an… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K062765.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072343: Neurovision JJB System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072343
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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