510(k) · Cleared
ClearedALARA Neuro Access Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SurGenTec, LLC · PDQ Neurosurgical Nerve Locator
Cleared on Jul 16, 2019 as substantially equivalent to K171807 (Stryker Corporation, 2017) after a 166-day review. Its family tree reaches back 11 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 16, 2019
- Review
- 166 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K950697 (1995). 100 ancestors in all, the oldest K842956 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations between
- 3 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 2 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 1 generation backK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- This deviceK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
- Descendant · cites it directly · 1 of its ownK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
- Descendant · cites it directly · 0 of its ownK243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2025
Show all 11 generations
- Root · 11 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 10 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 9 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 7 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 6 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 5 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 4 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 3 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 2 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 1 generation backK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- This deviceK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −10 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −9 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −7 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −6 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −5 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −4 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −3 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| −2 | K140400 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2014 | — |
| −1 | K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017 | — |
| 0 (this device) | K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019 | — |
| +1 | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024 | — |
| +1 | K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K171807 | ES2 Neuromonitoring Accessory InstrumentsSummary page 4…Predicate Device: - 510k Product Name Clearance Date K171807 ES2 Neuromonitoring Accessory July 18,2017 Instruments Indication for Use:… | 2017 |
What descends from it? (2)
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 24 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 100 ancestors have a recall of any class.
- Of its descendants, K240664 (SurGenTec, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K171807.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The ALARA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190163: ALARA Neuro Access Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190163
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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