510(k) · Cleared
ClearedPhantom XL Insulated Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TeDan Surgical Innovations, Inc. · GXZ Electrode, Needle
Cleared on Jun 29, 2023 as substantially equivalent to K140088 (Tedan Surgical Innovations, LLC, 2014) after a 20-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- Jun 29, 2023
- Review
- 20 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K980148 (1998). 14 ancestors in all, the oldest K850107 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 6 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 5 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 4 generations backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- 3 generations backK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- 2 generations backK110419 Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011
- 1 generation backK140088 Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC · 2014
- This deviceK231691 Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253580 Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile…Tedan Surgical Innovations · 2026
Most influential descendants
Showing 1 of 1 · See all- K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −6 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −5 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −4 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| −3 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| −2 | K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators | Stryker Spine | 2011 | — |
| −1 | K140088 | Phantom XL Insulated Dilators | Tedan Surgical Innovations, LLC | 2014 | — |
| 0 (this device) | K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | 2023 | — |
| +1 | K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated… | Tedan Surgical Innovations | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 GXZ? 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 GXZ device
- #1 K241045 Disposable Subdermal Needle Electrode, Corkscrewscore 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? (1)
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 |
|---|---|---|---|
| * | K140088 | Phantom XL Insulated DilatorsSummary page 4…fication Name: Neurosurgical nerve locator, 21 CFR 874.1820 (PDQ) A. Predicate Device The predicate device is the Phantom XL Insulated Dilators (K140088) also manufactured by TeDan Surgical Innovations, Inc. B. Device Description TSI’s Phantom XL Insulated Dilators are used as ins… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm… | 2026 | 0 |
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 25 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K253580 (Tedan Surgical Innovations, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GXZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXZ
102in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXZ
75in 2025
MAUDE reports naming product code GXZ, 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 | 102 | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 19 | 4 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231691 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231691: Phantom XL Insulated Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231691
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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