510(k) · Cleared
ClearedNIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Endo Surgical Tech, · PDQ Neurosurgical Nerve Locator
Cleared on Aug 22, 2018 as substantially equivalent to K031003 (Medtronic Xomed, Inc., 2003) and 1 other predicate after a 174-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Aug 22, 2018
- Review
- 174 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K980148 (1998). 13 ancestors in all, the oldest K842956 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 3 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 2 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 1 generation backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- This deviceK180542 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech, · 2018
- Descendant · cites it directly · 0 of its ownK182662 NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech, · 2019
Most influential descendants
Showing 1 of 1 · See all- K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech, · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −3 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −2 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −1 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| 0 (this device) | K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | 2018 | — |
| +1 | K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesSummary page 4…Neurology Regulatory Class: II Product Code: PDQ III. PREDICATE DEVICE Medtronic Stimulation/Dissection Instruments, Ball-tip probes, K031003 Medtronic NIM Spine, K031510 No reference devices. IV. DEVICE DESCRIPTION The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe a… | 2003 |
| * | K031510 | Nim-SpineSummary page 4…ss: II Product Code: PDQ III. PREDICATE DEVICE Medtronic Stimulation/Dissection Instruments, Ball-tip probes, K031003 Medtronic NIM Spine, K031510 No reference devices. IV. DEVICE DESCRIPTION The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are single use devices compose… | 2003 |
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 |
|---|---|---|---|
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | 2019 | 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 20 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K182662 (Boston Endo Surgical Tech,, 2019) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K031003.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are indicated for pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180542: NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180542
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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