510(k) · Cleared
ClearedPediguard Nerve Detector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Vision, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Dec 29, 2004 as substantially equivalent to K980148 (The Magstim Company, Ltd., 1998) and 2 other predicates after a 679-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it.
- Decided
- Dec 29, 2004
- Review
- 679 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921979 (1993). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 2 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 1 generation backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- This deviceK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
- Descendant · cites it directly · 4 of its ownK143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2…Spineguard S.A. · 2015
- Descendant · 2 generations on · 3 of its ownK152747 DSG Threaded Drill SystemSpineguard S.A. · 2016
- Descendant · 3 generations on · 2 of its ownK162884 SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
- Descendant · 2 generations on · 1 of its ownK201454 DSG Connect TechnologySpineguard S.A. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123390Pediguard Nerve Detector SystemSpineguard S.A. · 2013 · cites it directly5descendants
- K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard…Spineguard S.A. · 2015 · cites it directly4descendants
- K152747DSG Threaded Drill SystemSpineguard S.A. · 2016 · 2 generations on3descendants
- K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017 · 3 generations on2descendants
- K201454DSG Connect TechnologySpineguard S.A. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −2 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −1 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| 0 (this device) | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| +1 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
| +1 | K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated… | Spineguard S.A. | 2015 | — |
| +2 | K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016 | — |
| +3 | K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017 | — |
| +2 | K201454 | DSG Connect Technology | Spineguard S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K980148 | Neurosign 800, 8 Channel Motor Nerve MonitorSummary page 1…Product code: 77 ETN SUBSTANTIALLY EQUIVALENT DEVICES: Neurosign 800, Magstim Company, Ltd. (K980148) NuVasive, Inc.'s INS-1 Intraoperative Nerve… | 1998 |
| * | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemSummary page 1…(K980148) NuVasive, Inc.'s INS-1 Intraoperative Nerve Surveillance System (K002677) TOEI Electric Co., Ltd.'s JUSTWO Model TME-… | 2000 |
| * | K022020 | Justwo Model Tme-601 Root Apex LocatorSummary page 1…e System (K002677) TOEI Electric Co., Ltd.'s JUSTWO Model TME-601 Root Apex Locator (K022020) DEVICE DESCRIPTION AND INTENDED USE: The PediGuard System is a hand held, battery operated bi-polar probe that is comprised of… | 2002 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K123390 (Spineguard S.A., 2013) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K980148.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030526: Pediguard Nerve Detector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030526
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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