510(k) · Cleared
ClearedSterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tedan Surgical Innovations · PDQ Neurosurgical Nerve Locator
Cleared on Apr 26, 2026 as substantially equivalent to K231691 (TeDan Surgical Innovations, Inc., 2023) after a 160-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Apr 26, 2026
- Review
- 160 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K980148 (1998). 15 ancestors in all, the oldest K850107 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 7 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 6 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 5 generations backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- 4 generations backK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- 3 generations backK110419 Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011
- 2 generations backK140088 Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC · 2014
- 1 generation backK231691 Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. · 2023
- This deviceK253580 Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile…Tedan Surgical Innovations · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −7 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −6 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −5 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| −4 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| −3 | K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators | Stryker Spine | 2011 | — |
| −2 | K140088 | Phantom XL Insulated Dilators | Tedan Surgical Innovations, LLC | 2014 | — |
| −1 | K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 PDQ? 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 PDQ device
- #1 K243636 Neuralytix iD3 System (NTX-9001)score 16.5 · 14 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 |
|---|---|---|---|
| * | K231691 | Phantom XL Insulated DilatorsSummary page 5…Reference Device Device Name Phantom XL Insulated Dilators CD Horizon™ Navigated Instruments 510(k) Number K231691 K182121 FDA Regulation 21 CFR §882.1350, 21 CFR §874.1820 21 CFR §882.4560… | 2023 |
| † | K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition | 2018 |
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 28 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PDQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDQ
182in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDQ
No recall names PDQ since 2007.
Adverse event reports per year · PDQ
2in 2025
MAUDE reports naming product code PDQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 5 | 181 | 0 | 1 |
| 2014 | 7 | 254 | 0 | 0 |
| 2015 | 3 | 95 | 0 | 1 |
| 2016 | 3 | 100 | 0 | 4 |
| 2017 | 2 | — | 0 | 5 |
| 2018 | 4 | 162 | 0 | 5 |
| 2019 | 4 | 182 | 0 | 10 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Spine surgery for sequential dilation and to deliver an electrical stimulation to the tissue and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure. Navigated ø5mm Insulated Dilator is intended to be used during spinal surgery to assist the surgeon in precisely establishing the desired access trajectory. Navigated ø5mm Insulated Dilator is specifically designed for use with Medtronic Stealth™ Systems, where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, or fluoroscopy images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253580: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253580
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026